Instruments for functional explorations and therapeutic interventionsOrthopaedic instrumentsMotorised orthopaedic surgery system instruments
Motorised orthopaedic surgery system instruments - hardware accessories
EMDN code Z12130580
Manufacturers registered in Europe (EUDAMED) 13
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 63
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 |
|---|---|---|---|
| Bien-Air Surgery SA Present in Europe in other categories | Switzerland | Bur PM2-95 80K Diam C Ø6.0 St Bur PM2-70 80K Diam Ø4.0 St Bur PM2-70 80K FC Ø2.0 St Bur PM2-95 80K Diam Ø1.0 St Bur PM2-125 80K Diam Ø4.0 St Bur PM2 80K Steel TD Ø1.1x4 St | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | RAD® ViSAO® ApexCut Oto-Flex Tricut® | K041985 (2004) |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | GYRUS ACMI Diego Elite DIEGO | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| EON MEDITECH PRIVATE LIMITED | – | OSSEOUS Burs-Tungsten Carbide OSSEOUS Burs-stainless Steel OSSEOUS Burs-Fine Diamond OSSEOUS Burs-Course Diamond OSSEOUS OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type | registered |
| WEXLER SURGICAL, INC. | United States | Wexler Surgical, Inc. SA-DB5 SA-DB2L SA-FB4 SA-DB3 SA-C-FB4L | registered |
| INVOTEC INTERNATIONAL, INC. | United States | Invotec ENT Bur | registered |
| Grace Medical, Inc. | United States | DragonFly™ Skinny BUR, 100MM x 1.4MM DragonFly™ BUR, CTR, EGG, 80MM L, 1.8MM Ø, BurShield DragonFly™ BUR, DMD, RD, 95MM L, 1.8MM Ø DragonFly™ BUR, DMD, RD, 95MM L, 2.3MM Ø, BurShield DragonFly™ BUR, CTR, RD, 80MM L, 1.8MM Ø, BurShield DragonFly™ BUR, CTR, RD, 80MM L, 1.4MM Ø, BurShield | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| Hager & Meisinger Gesellschaft mit beschränkter Haftung | – | – | registered |
| Acra Cut, Inc. | United States | Disposable Cranial Perforator ACRA-CUT Acra-Cut Reusable Cranial Perforator | K032970 (2003) |
| Micromar Indústria e Comércio Ltda Present in Europe in other categories | Brazil | EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm | registered |
| Provision | – | Gyrus ACMI Medtronic Stryker Karl Storz Entellus Medical | registered |
| evonos GmbH & Co. KG | Germany | Evonos | K231403 (2024) |
| INTEGRA MICROFRANCE Present in Europe in other categories | France | MicroFrance® | registered |
| Conmed Corporation Present in Europe in other categories | United States | RHINOTEC GATOR RHINOTEC CUDA RHINOTEC MICROXCISOR RHINOTEC | registered |
| EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság Present in Europe in other categories | – | NeuroLine | registered |
| SURETEK MEDICAL | United States | Reprocessed 2.5mm Straight Shaver Blade Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated Reprocessed 4mm Straight Shaver Blade Reprocessed Shaver Blade Straight 3.5mm Double Serrated Reprocessed Shaver Blade Straight 2.1mm Double Serrated Reprocessed Shaver Blade Straight 3.0mm Double Serrated | registered |
| adeor Medical AG | Germany | Meridian Perforator | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® CODMAN® | registered |
| BIOMET MICROFIXATION, INC Present in Europe in other categories | United States | – | registered |
| The Anspach Effort, Inc. | United States | – | K082637 (2008) |
| AD Supply Group Limited | United Kingdom | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Acumed Instruments Corp. | United States | – | registered |
| B & M Precision, Inc. | United States | – | registered |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | – | registered |
| Berger Surgical Medical Products GmbH | Germany | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti | Türkiye | – | registered |
| Coba Biomedical PTY (Ltd) | South Africa | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | – | registered |
| EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG | Germany | – | registered |
| Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | Hungary | – | K213228 (2022) |
| Eon Meditech Pvt. Ltd. | India | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Gesco Healthcare Private Limited | India | – | registered |
| Guizhou Zirui Technology Co., Ltd. | China | – | K254177 (2026) |
| HAFNER CHIRURGISCHE INSTRUMENTE | Germany | – | registered |
| HAGER & MEISINGER GMBH | Germany | – | registered |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Integra LifeSciences Corporation Present in Europe in other categories | United States | – | K183581 (2019) |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. Present in Europe in other categories | China | – | registered |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| MSK Precision Products, Inc. | United States | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Manman Manufacturing Company Private Limited | India | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | – | registered |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Olympus America, Inc. Present in Europe in other categories | United States | – | registered |
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI | Türkiye | – | registered |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Unique Instruments Inc. | United States | – | registered |
| VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. | Türkiye | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
| XINHUA SURGICAL INSTRUMENT CO. LTD. | China | – | registered |
| YAMMI HUMMINGBIRD MEDICAL TECHNOLOGY (SUZHOU) CO., LTD. | China | – | registered |
| ZONEFLY MEDICAL DEVICES CO., LTD. | China | – | registered |
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