Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments
Various instruments for general and multidisciplinary surgery
EMDN code Z120190
Manufacturers registered in Europe (EUDAMED) 128
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 1,990
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| RAZEK EQUIPAMENTOS LTDA | Brazil | RAZEK EQUIPAMENTOS | registered |
| Medacta International S.A. Present in Europe in other categories | Switzerland | SportMed Instruments Surgical Manual Instrument Knee Instruments Spine Instruments Hip Instruments | registered |
| VB Spine LLC | United States | LITe® Pedicle Based Retractor K2M General Instruments ALEUTIAN Interbody Systems CANYON™ Retractor Systems ALEUTIAN® Interbody Systems EVEREST Spinal System | registered |
| Globus Medical, Inc. Present in Europe in other categories | United States | StelKast Generic Knee instruments ORTHOPEDIC MANUAL SURGICAL INSTRUMENT StelKast Generic Hip instruments CREO MONUMENT | registered |
| Nuvasive, Inc. Present in Europe in other categories | United States | ReLine MaXcess NuVasive Modulus CoRoent XLIF | registered |
| SPINAL ELEMENTS, INC. | United States | OVERWATCH ZEUS-T SAVANNAH INCORPORATE ZEUS-O ZEUS-P | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | POWERPULSE R3 EVOS ACUFEX Anthology Capture High Torque Screw System | K152163 (2016) |
| Howmedica Osteonics Corp. Present in Europe in other categories | United States | INSTRUMENT Specialty DSA Retractor Pin Instruments | registered |
| Ortho Development Corporation | United States | – | registered |
| Thompson Surgical Instruments, Inc. Present in Europe in other categories | United States | Thompson | registered |
| Avalign Technologies, Inc. | United States | Millennium Avalign Orthofix Alphatec Spine Stryker Spine | registered |
| Surgical Direct, Inc. | United States | Surgical Direct | registered |
| KYOCERA MEDICAL TECHNOLOGIES, INC. | United States | Kyocera Medical Technologies, Inc. | registered |
| Choice Spine, LP | United States | Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™) TOMCAT™ Cervical Spinal System VEO® Lateral Interbody Fusion System Acapella One HARRIER™ Choice Spine Intervertebral Body Device STEALTH™ Anterior Cervical Interbody Spacer | registered |
| ALPHATEC SPINE, INC. | United States | General Instruments General Instrument Invictus Illico Sigma | registered |
| Seaspine Orthopedics Corporation | United States | NewPort Specials Lateral Retractor Lattus NewPort™ Fathom | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | Bio-Modular® Comprehensive® Instruments Vanguard® COMPREHENSIVE INSTRUMENTATION BLUNT SHOULDER RETRACTOR MICROPLASTY® RETRACTOR Comprehensive® Instrumentation | registered |
| ELMED INCORPORATED | United States | ELMED ELMED INCORPORATED ELME | registered |
| Orthofix US LLC Present in Europe in other categories | United States | SKYHAWK TRUELOK ORTHOFIX GALAXY FIXATION GEMINI PILLAR XL FIREBIRD SFS | registered |
| Zimmer, Inc. Present in Europe in other categories | United States | Retractor NexGen® Comprehensive MIS Natural Nail® Trauma | K830287 (1983) |
| NOVO SURGICAL, INC. | – | Novo Surgical Inc. Novo Surgical Novo Surgical Inc Novosurgical | registered |
| Highridge Medical, LLC | United States | Timberline Lateral Fusion System Alta ACDF System Mergence-A Preparation Instrumentation Disc Preparation Instruments Vital Spinal Fixation System TM Ardis Interbody System | registered |
| Synthes GmbH Present in Europe in other categories | United States | Matrix USS SynFrame PRODISC L ACF | registered |
| RZ-Medizintechnik GmbH Present in Europe in other categories | Germany | RZ Medizintechnik GmbH Stopcock | registered |
| TEDAN SURGICAL INNOVATIONS, L.L.C. Present in Europe in other categories | United States | Stryker TSI Zimmer Lattus Terumo | registered |
| Life Instrument Corporation Present in Europe in other categories | United States | Life Instruments Life Instrument 749-1570-0-1 Life Intrusments M930706650810 | registered |
| SPINECRAFT, LLC | United States | ASTRA Spine System APEX Spine System PANORAMA ORIO-3D Cage System ASTRA-OCT Spine System ORIO | registered |
| KOROS U.S.A., INC. | United States | Hand Retractor Malleable Swivel Retractor Blue Boy Blade Lamina Spreader Black Belt Two-Level Ti Blunt Blade Kelly Swivel Retractor | K101609 (2010) |
| DEPUY SPINE, LLC | United States | PIPELINE ALIF KEYSTONE PLIF | registered |
| SONTEC INSTRUMENTS, INC. | United States | INGE LAMINA SPREADER BALFOUR RETRACTOR TURNER WARWICK UNIVERSAL RETRACTOR BLADE FINOCHIETTO RIB SPREADER RETRACTOR ATRIAL BLADE CASPAR RETRACTOR FRAME | registered |
| NEXXT SPINE, LLC | United States | Matrixx System TrellOss™ Inertia® CONNEXX™ Modular Pedicle Screw System Inertia® Pedicle Screw System TrellOss®-C SA NEXXT MATRIXX® Stand Alone Cervical-TL System | registered |
| SURTEX INSTRUMENTS LTD. Present in Europe in other categories | United Kingdom | Surtex | registered |
| SIGNATURE ORTHOPAEDICS PTY LTD | Australia | Acetabular Reamer Acetabular Reamers OriginPlus Broach Remedy Broach Aria Broach Spartan Stem Broach | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical Ambler Value Line | registered |
| GSOURCE LLC | United States | gSource | registered |
| TORNIER, INC. Present in Europe in other categories | France | Tornier Perform Made-To-Order Affiniti MaxLock Tornier Humeral Nail | registered |
| Acumed LLC | United States | ACUMED | registered |
| SIGNUS Medizintechnik GmbH | Germany | DIPLOMAT MONOPOLY INSTRUMENT CERCCESS CYLOX ST CONKLUSION | registered |
| INNOMED, INC. Present in Europe in other categories | United States | Innomed, Inc. Innomed,Inc. Innomed, Inc.l Innnomed, Inc. Innomed, Inc | registered |
| L&K BIOMED CO. ,LTD. | South Korea | LnK Spinal Instrument System CastleLoc Pectus Bar System Instrument Set AccelFix Spinal Fixation System Instrument Set CastleLoc Pectus Bar System LnK Spinal Instrument System LnK Spinal Instrument System | registered |
| CAMBER SPINE TECHNOLOGIES, LLC | United States | VARIANT ORTHROS Variant Retractor SPIRA®-O Open Matrix OLIF General Instrument SPIRA®-A Integrated | registered |
| SKLAR CORPORATION | – | Sklar® Sklar Sklar Instruments | registered |
| ALPHA AI CO.,LTD. | South Korea | 4CIS® INSTRUMENT SYSTEM 4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM 4CIS® Riviera Disposable Retractor System | registered |
| Provision | – | Arthrex Stryker Smith and Nephew Toby Orthopaedics Treace Medical Concepts Synthes | registered |
| TOTAL JOINT ORTHOPEDICS, INC. | United States | Stem Trial Tibial Insert Trial, PS-Max, Klassic ONE Tibial Insert Trial, Klassic ONE Tibial Insert Trial, PS-Post, Klassic ONE Tibial Insert Trial, PS-Post Klassic BiPolar Trial | registered |
| BOSS INSTRUMENTS, LTD., INC. | – | BOSS Instruments | registered |
| UNITED ORTHOPEDIC CORP. | Taiwan | U2™ Knee U2 Total Knee System USTAR II Knee System UKNEE™ DM Acetabular System Conformity Stem | registered |
| Evolution Spine LLC | United States | E3D-A Interbody System Whistler Modular Pedicle Screw System E3D®-C Interbody System Keystone ALIF System E3D-C Interbody System EMERGE Anterior Cervical Plate System | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING KMEDIC PLEUR-EVAC | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| Hayden Medical, Inc. | – | Hayden Medical | registered |
| MARINA MEDICAL INSTRUMENTS, INC. | United States | Marina Medical | registered |
| Spineology, Inc. | United States | SOAR Retractor System Medius Midline Retractor System Merlon Retractor System SOAR Portal Retractor System Medius Retractor System Duo Ti Expandable Interbody Fusion System | registered |
| Medicon eG. Chirurgiemechaniker-Genossenschaft | – | Medicon MediExpand Cervical Expandable VBR System Medicon Forceps Medicon Rod Pusher Medicon Sounding Probe Stern-a-Fix Sternal Closure System | registered |
| Depuy, Inc. | United States | INHANCE INTACT GLOBAL ENABLE DELTA XTEND GLOBAL P.F.C. CHARNLEY | K941896 (1994) |
| FLEXBAR MACHINE CORPORATION | United States | Bookler Table Mounted Retractor Systems Mediflex Universal Round Bar Table Mounted Retractor Systems Mini-Bookler Table Mounted Retractor Systems Holders and Positioners - Nathanson Hooks StrongArm Surgical Holders and Positioners Flexarm Plus Surgical Holders and Positioners | registered |
| CG MedTech Co.,Ltd. | South Korea | ANAX™ 5.5 CT SPINAL SYSTEM Velofix™ PEEK Lumbar Cage Maxima™ ACP System SurgVue™ MIDLINE RETRACTOR SET UniSpace® Stand-Alone C Cage ANAX™ 5.5 SPINAL SYSTEM | registered |
| DEGEN MEDICAL, INC. | United States | DeGen Standard Instrumentation Solar™ Interbody Fusion System Impulse Interbody Spacer System F1 MPS Cyclops Anterior Cervical Plate System E³ MIS Pedicle Screw System | registered |
| HNM STAINLESS, LLC. | – | HNM Medical | registered |
| Tyber Medical, LLC Present in Europe in other categories | United States | Anatomic Access LLIF Cannulated Screw System + Cannulated Compression Headless Screw Cannulated Headless Screw - Full Thread FPS Headless Screw System Instruments | registered |
| LIMACORPORATE SPA Present in Europe in other categories | Italy | PHYSICA LMC PHYSICA PS PRO PHYSICA HPS SMR Shoulder AMF REVISION TT CONES PRIMA | K222405 (2022) |
| MEDFIX INTERNATIONAL, LLC | – | Medfix | registered |
| Integrity Implants Inc. Present in Europe in other categories | United States | FlareHawk Toro | registered |
| Medos International Sàrl Present in Europe in other categories | Switzerland | PUREVUE TELIGEN EXPEDIUM CONDUIT T.L.I.F. | registered |
| Microport Orthopedics Inc. Present in Europe in other categories | United States | ODYSSEY® PROFEMUR® MicroPort CONSERVE® ADVANCE® | registered |
| Modern Surgical Instruments LLC | – | MSI | registered |
| WRIGHT MEDICAL TECHNOLOGY, INC. Present in Europe in other categories | – | Made-To-Order TCP EVOLVE Incompass Total Ankle System SALVATION | registered |
| ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION | United States | ASSI | registered |
| Ascension Orthopedics, Inc. | – | Integra® Salto Talaris® NuGrip® Cadence™ Titan™ Panta® 2 | registered |
| T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | – | Nitinol Loop Passer MEDACTA Slider Nitinol Shuttle (1 unit - lb1) Slider Nitinol Shuttle (5 units - lb2) Wire Penetrating Grasper Straight Tissue Grasper with Ratchet | registered |
| Spineup, Inc. | – | ROMERO Lordotic Rasp 20x12, H04mm ROMERO Lordotic Rasp 20x12, H08mm ROMERO Lordotic Rasp 20x12, H12mm Implant Holder with Drill Guides W20 x H04 mm ROMERO Lordotic Rasp 20x12, H10mm ROMERO Lordotic Rasp 20x12, H09mm | registered |
| FX SOLUTIONS | – | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Humelock II Cemented Shoulder System Humelock Reversed Shoulder Humeral Cup Stability Humeris Shoulder Humelock II Cemented Reversible Shoulder | registered |
| ADVANCED ORTHOPAEDIC SOLUTIONS, INC. | – | SCREW SHEATH REDUCTION TOOL TIBIAL NAIL TARGETING MODULE, TROCHANTERIC NAIL 125°/20cm Calibrated Drill (AO Style), 5.5mm AOS DRILL GUIDE 4.0mm PIN GUIDE, BLOCKING SCREW TARGETING ARM 2.0mm | registered |
| ORTHO-MED, INC. | United States | ORTHOMED ORHTOMED | registered |
| Nsi US | United States | – | registered |
| GS Medical Co., Ltd. | South Korea | AnyPlus® PYXIS 3D Titanium Cervical Cage System PYXIS 3D Titanium Cage System QUASAR Standalone ACIF System GluOn-IF AnyPlus Spinal Fixation System | registered |
| Medartis AG Present in Europe in other categories | Switzerland | APTUS MODUS Stratum Ankle Stealthfix Intraosseous Fixation System InCore TMT InCore MPJ | registered |
| PRECISION SPINE, INC. | United States | Intervertebral Body Fusion Device MD Vue Lateral Access Reform MC Screw System MD-Max ULIF Reform Ti Modular MD-Vue™ Lateral Access System | registered |
| Medyssey Co., Ltd. | South Korea | – | registered |
| GPC MEDICAL LIMITED | India | GPC | registered |
| Gimmi GmbH Present in Europe in other categories | Netherlands | Gimmi | registered |
| CAPTIVA SPINE, INC. | United States | SmartLOX Cervical Plate System TransFasten Non-Modular 6° Lordotic Trial Assembly Non-Modular Convex Trial Assembly Set Screw Starter Screw Adjuster | registered |
| NGMedical GmbH | – | BEE BEE PLIF NGM WAVE BEE HA | registered |
| ORTHOPEDIATRICS CORP. Present in Europe in other categories | United States | General Instrument 3P Small-Mini Frag System Periacetabular Osteotomy System PediNail Intramedullary Platform Response 5.5/6.0 Spine System Vilex Tool | registered |
| Biedermann Motech GmbH & Co. KG | Germany | – | registered |
| SPINEVISION | United States | UNI-THREAD® Hexanium® TLIF P.L.U.S.® Hexanium® ACIF Hexanium® PLIF | registered |
| Automated Medical Products Corp. | United States | Iron Intern II Ring Retractor Stieber Iron Intern Ring Giulianotti Iron Intern ARM | K942818 (1994) |
| Buxton Biomedical Inc | United States | Buxton BioMedical Mic.Pit Bayo Rong,str,180X1mm | registered |
| Omni Life Science, Inc. Present in Europe in other categories | – | APEX Knee System Corin Hip Systems Trinity System Unity Knee System OMNIBotics OMNI Interface Acetabular System | registered |
| GM DOS REIS INDUSTRIA E COMERCIO LTDA | Brazil | Orthopedic Instruments MICA Guide Orthopedic Instrument Orthopedic manual surgical instrument Meniscus Suture - OUT IN MICRO EASYPASS | registered |
| NVision Biomedical Technologies, Inc. | United States | Trigon EARP Retractor Impact Toejack nvp FOCUS | registered |
| FENTEX medical GmbH Present in Europe in other categories | Germany | FENTEX | registered |
| American Medicals | – | American Medicals | registered |
| Batrik Medical Manufacturing Inc Present in Europe in other categories | Canada | Sterile Pin-Kaps Batrik Pin Guards Batrik Pin Kaps Batrik Pin-Kaps Batrik Pin Guard\.054"\Dark Red w/sleeve Batrik Pin Guard\.054"\Dark Red | registered |
| Zsfab, Inc. | United States | ZSFab Cervical Surgical Instrument ZSFab TLIF Instrument ZSFab Lumbar Surgical Instrument ZSFab PLIF Universal Instrument ZSFab Customized PLIF Instrument ZSFab Customized Lumbar Instrument | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Industries, Inc. Medline MEDLINE INDUSTRIES MEDLINEUNITE MEDLINE UNITE PENDING | K213068 (2022) |
| Zavation LLC | – | ZAVATION SCREWDRIVER Zavation ZAVATION TAP ZAVATION DRIVER ZAVATION CADDY Zavation Medical Products, LLC | registered |
| NEXT ORTHOSURGICAL, INC. | – | EZ-Track Nex-D2 | registered |
| Encore Medical, L.P. | United States | DJO SURGICAL | registered |
| CTL Medical Corporation | United States | GENERIC Surgical Instruments | registered |
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