Manufacturer

Synthes

SwitzerlandLegal entities : Synthes GmbH

First countries of placing on the market declared in EUDAMED : Belgium

EU representative : DePuy Ireland UC (Ireland)

9 categories, 153 models including 132 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Various orthopaedic and traumatology instruments - other	Z12139099	03.111.100S93/42 BME ELITE5 refs Cable Passing tube Cervical Distractor Screw2 refs Cervical Retractor Blade U22-7522403 refs 62 others Connecting Screws for Sizing Templates Coupling Instruments for Spine3 refs DHS3 refs Guide Wires for Spine3 refs INSIGHT Access Tube3 refs INSIGHT Lateral Access Blade3 refs INSIGHT Lateral Access Blade Fixation Screw INSIGHT Lateral Access Disposable Light INSIGHT Lateral Access Holder INSIGHT Lateral Access Retractor Body INSIGHT Lateral Access Reusable Light INSIGHT Retractor Blade3 refs INSIGHT Retractor Disposable Light LCP USFS 3D Templates3 refs MATRIX3 refs MatrixMANDIBLE6 refs Non-Invasive Devices for Spine - Instrument3 refs Non-Invasive Devices for Spine - Light Connecting Device3 refs Non-Invasive Devices for Spine - Packing Block3 refs Orthopaedic Drill Guide Single use 03.111.112S Orthopaedic Extraction Hook single use Orthopaedic Extraction Screws single use 03.213.020S2 refs Orthopaedic Lever and Elevator3 refs Orthopaedic Spreader3 refs Orthopaedic Threaded Drill Guide Single use Orthopaedic Torque-limiting Screwdriver Orthopaedic Torque-limiting Stop for Screwdriver Orthopaedic Trocars - Single use 03.043.008S2 refs Outer Protection Sleeves for Suprapatellar Instruments Set2 refs Patella Template Kit2 refs Radial Head Replacement Instrument Kit 03.405.000S Radiolucent Pelvic Retractors3 refs RapidSorb Surgical Bending Template3 refs Single Use Instruments Spine Extraction Screw 03.617.971S Single Use Instruments Spine Protection Sleeve 03.835.012S Single Use Instruments Spine Trial Rod3 refs Single Use Instruments Threaded Rod Spine Access Kit 10G3 refs Spine Access Kit 4.7mm Spine Augmentation Cleaning Stylet2 refs Spine Biopsy Kit 03.804.522S2 refs Spine Screw Augmentation Adapter Spine Trial Implants for ACIS3 refs Spine Trial Implants for ARCH3 refs Spine Trial Implants for Cervios3 refs Spine Trial Implants for Opal3 refs Spine Trial Implants for SYNFIX Evolution3 refs Spine Trial Implants for T-PAL3 refs Spine Trial Implants for XRL Medium3 refs Spine Trial Implants for Zero-P3 refs Spine Trial Implants for Zero-P VA3 refs Suprapatellar protection sleeves for Tibia Nail Advanced3 refs SYNAPSE Spinal Templates for Spine3 refs SYNFRAME6 refs TRAUMACEM V+2 refs Trial Implant for Distal Radius Plate Trial Implants for VA-LCP 2-Column Distal Radius Plates USS 388.87093/42 USS 388.88093/42 VERTECEM ORACLE3 refs (no longer marketed) ORACLE Retractor Disposable Light (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - other	Z12130599	Bone Harvesting KIT for RIA 2 DCS3 refs DHS\|DCS3 refs Drive Shaft for RIA 2 Flexible Shaft for Reamers Power driven2 refs 17 others Handle for 90° Screwdriver2 refs MatrixRIB Screwdriver Blade for 90° Screwdriver Orthopaedic Centering Pins Power Driven Stainless Steel3 refs Orthopaedic Reduction Joysticks2 refs Orthopaedic Torque Limiting Instruments - Power driven3 refs Orthopaedic Wires Power Driven Cobalt Alloy - Reusable Orthopaedic Wires Power Driven Cobalt Alloy - Single Use3 refs Orthopaedic Wires Power Driven Stainless Steel - Reusable3 refs Orthopaedic Wires Power Driven Titanium Alloy2 refs Q Insertion Screw Loader Device Q Insertion Screw Screwdriver Shaft Reamer Head for RIA 23 refs Reaming KIT for RIA 2 Retention Pin Stainless Steel2 refs Screwdriver Shaft MatrixMANDIBLE, MatrixMIDFACE for 90° Screwdriver3 refs Screwholder for 90° Screwdriver3 refs STARDRIVE3 refs	IIa MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	Attachments for Small Bone Pen-Shaped Power Tools20 refs Attachments for Small Bone Pistol-Shaped Power Tools6 refs Battery Power Line II3 refs Battery Power Line II Attachments4 refs Colibri II3 refs 19 others Compact Air Drive II2 refs Compact Air Drive II Attachments7 refs Electric Pen Drive5 refs Irrigation Tubing, Irrigation Clips and Hoseclips2 refs KINCISE17 refs Power Tools Air Accessories2 refs Power Tools Maintenance Auxiliaries11 refs Synthes Cutting Tools12 refs Trauma Recon System4 refs Trauma Recon System Attachments5 refs UNIUM3 refs Universal Battery Charger II2 refs ANSPACH Dissection Tools3 refs (no longer marketed) ANSPACH\|EG16 refs (no longer marketed) ANSPACH\|EG1 G1 Minimal Access Angle Driver (no longer marketed) ANSPACH\|EG1 G1 Perforator Driver (no longer marketed) ANSPACH\|EG1 G1 Straight and Angle Attachments3 refs (no longer marketed) ANSPACH\|EG1\|Otologic Curved Micro (OCM) G1 Otologic Curved Micro Attachment (no longer marketed) ANSPACH\|Otologic Curved Micro (OCM)3 refs (no longer marketed)	I, IIa MDR	EUDAMED record Report an error
Orthopaedic surgical drills	Z12130503	Bone Taps single use Drill Bits for Spine3 refs MatrixMANDIBLE3 refs Orthopaedic Drill Bit - Power Driven - Reusable3 refs Orthopaedic Drill Bit - Power Driven - Single Use3 refs 13 others Orthopaedic Drill Bit - Screw Extraction - Reusable2 refs Orthopaedic Drill Bit - Screw Extraction - Single Use 03.401.075S3 refs Tap for Resorbable screws3 refs ZERO-P 03.617.975S93/42 03.505.054S93/42 (no longer marketed) 316.150S93/42 (no longer marketed) 316.180S93/42 (no longer marketed) 316.230S93/42 (no longer marketed) 316.521S93/42 (no longer marketed) 316.530S93/42 (no longer marketed) 316.540S93/42 (no longer marketed) 316.730S93/42 (no longer marketed) 317.260S93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Motorised orthopaedic surgery systems	Z12130501	Battery Power Line II3 refs Compact Air Drive II Attachments Electric Pen Drive3 refs KINCISE Trauma Recon System2 refs 4 others UNIUM2 refs ANSPACH\|EG1 G1 Electric Consoles2 refs (no longer marketed) ANSPACH\|EG1 G1 High Speed Electric Handpiece (no longer marketed) Colibri II2 refs (no longer marketed)	IIa MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - other	Z12011399	Advanced Nail System3 refs Cases for Spinal Medical Devices3 refs KINCISE3 refs Power Tools Washing Baskets and Cases3 refs Power Tools Washing Baskets and Cases Power Tools Baskets and Cases (Cleaning & Sterilization - G1 Baskets)3 refs	I MDR	EUDAMED record Report an error
Implant measurement devices not included in other classes	V030204	DHS\|DCS6 refs LCP3 refs Orthopaedic Depth Gauge - Single Use 03.111.114S Spinal Instruments with a Measuring Function - Systems for Measurement, Implants3 refs	I, IIa MDR	EUDAMED record Report an error
Calipers	V030201	MatrixMANDIBLE3 refs Spinal Instruments with a Measuring Function - Callipers2 refs	I MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - consumables	Z12130585	ANSPACH\|Irrigation Tubing and Clips4 refs Power Tools Maintenance Auxiliaries4 refs	I, IIa MDR	EUDAMED record Report an error

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