Data / Medical devices / Switzerland / Synthes GMBH

Synthes GMBH: FDA-registered device maker in Selzach Solothurn, Switzerland, 350 510(k) clearances and 1 PMA approval

Name: Synthes GMBH FDA registration, clearances, approvals and recalls
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License: https://creativecommons.org/licenses/by/4.0/

Synthes GMBH is registered with the FDA (registration 3000270450) in Selzach Solothurn, Switzerland. It lists 90 device types. The FDA files 350 510(k) clearances and 1 PMA approval under its listings, the newest dated June 11, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3000270450
Address: Industriestrasse 28, Selzach Solothurn, Switzerland, 2545 Selz.
Owner or operator: SYNTHES GMBH / Synthes Produktions GmbH (9071542)
Roles: Exporter to the US, Manufacturer
First device listed: February 24, 1981
Registered through: 2027
Brand names listed: 2.4/2.7mm VA-LCP Forefoot/Midfoot, 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES, 2.4mm Cannulated Compression Screw, 2.4mm Cannulated Screw, 2.4mm VA LCP Two Column Volar DR, 2.4mm Variable Angle LCP Volar Rim Distal Radius System, 3.5 / 4.5 MM LCP METAPHYSEAL PLATES, 3.5 MM LCP DISTAL HUMERUS SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Bit, Surgical	GFG	1	Manufacturer	accessdata.fda.gov
Bone Cement	LOD	2	Manufacturer	accessdata.fda.gov
Broach	HTQ	1	Manufacturer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Caliper	KTZ	1	Manufacturer	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Manufacturer	accessdata.fda.gov
Chisel, Bone, Surgical	EML	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Manufacturer	accessdata.fda.gov
Condylar Plate Fixation Implant	JDP	2	Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Manufacturer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Manufacturer	accessdata.fda.gov
Driver, Wire, And Bone Drill, Manual	DZJ	2	Manufacturer	accessdata.fda.gov
Dura Substitute	GXQ	2	Manufacturer	accessdata.fda.gov
External Mandibular Fixator And/Or Distractor	MQN	2	Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Fastener, Plate, Cranioplasty	HBW	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Manufacturer	accessdata.fda.gov
Growing Rod System	PGM	2	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Implant, Fixation Device, Spinal	JDN	2	Manufacturer	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Manufacturer	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Metal	EZX	2	Manufacturer	accessdata.fda.gov
Motor, Drill, Pneumatic	HBB	2	Manufacturer	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-Alterable	GXN	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Exporter to the US	accessdata.fda.gov
Prosthesis, Condyle, Mandibular, Temporary	NEI	2	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Exporter to the US	accessdata.fda.gov
Retention Device, Suture	KGS	1	Manufacturer	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer	accessdata.fda.gov
Saw	HSO	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Spinal Pedicle Screw, Fixation, Appliance System	MCV	3	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Manufacturer	accessdata.fda.gov
Starter, Bone Screw	HWD	1	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
System, Applicator, Radionuclide, Remote-Controlled	JAQ	2	Manufacturer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Exporter to the US	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 350.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 11, 2026	K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System	KTT	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
March 10, 2026	K254093	DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
March 9, 2026	K260069	DePuy Synthes VOLT Proximal Tibia 3.5 Plating System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
March 28, 2025	K241927	Synthes Graphic Case & Tray System	KCT	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
May 9, 2024	K233967	DePuy Synthes MatrixSTERNUM Fixation System	HRS	Substantially Equivalent	Synthes GmbH	accessdata.fda.gov
March 21, 2024	K233665	DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
July 26, 2023	K231922	DEPUY SYNTHES MAXFRAME AUTOSTRUT System	KTT	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
January 6, 2021	K202810	AutoStrut G2	KTT	Substantially Equivalent	Orthospin, Ltd.	accessdata.fda.gov
July 18, 2019	K190895	MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 3, 2019	K190409	MatrixRIB Fixation System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
December 6, 2018	K181231	DePuy Synthes T-PAL Spacer System	MAX	Substantially Equivalent	Depuy Synthes Spine	accessdata.fda.gov
October 19, 2018	K180213	Titanium TomoFix Medial High Tibia Plate Anatomical	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
October 16, 2018	K182154	Depuy Synthes Femoral Neck System	KTT	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
October 4, 2018	K181949	SYMPHONY OCT System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 11, 2018	K173787	X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System	MQP	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 5, 2018	K172872	DePuy Synthes Femoral Neck System	KTT	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
December 21, 2017	K172185	Tyber Medical PT Interbody Spacer System	ODP	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
November 14, 2017	K172157	DePuy Synthes Femoral Recon Nail System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 28, 2017	K170802	TRAUMACEM V+ Injectable Bone Cement	LOD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
July 20, 2017	K171439	EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System	KWQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 29, 2017	K162124	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	JDP	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
February 16, 2017	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw	HWC	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
February 9, 2017	K163046	DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
November 10, 2016	K161417	DePuy Synthes MAXFRAME Multi-Axial Correction System	KTT	Substantially Equivalent	Synthes USA, LLC	accessdata.fda.gov
November 3, 2016	K161590	MatrixRIB Fixation System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 26, 2016	K160167	DePuy Synthes TFNA Augmentation System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
July 1, 2016	K160904	Expedium Spine System, VIPER and VIPER 2 Systems	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
December 2, 2015	K152239	Zero-P Natural Plate System	KWQ	Substantially Equivalent	Synthes (Usa), LLC	accessdata.fda.gov
September 3, 2015	K151885	SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System	NKG	Substantially Equivalent	Depuy Synthes, Inc.	accessdata.fda.gov
August 21, 2015	K150673	SYNFIX Evolution Secured Spacer System	OVD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 23, 2015	K150796	Dental Bone Cutting Instruments	DZJ	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 18, 2015	K151276	DePuy Synthes T-PAL Ti Spacer	MAX	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
March 30, 2015	K141527	DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
March 27, 2015	K141385	DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)	HBW	Substantially Equivalent	Depuy Synthes Companies of Johnson & Johnson	accessdata.fda.gov
March 23, 2015	K150099	Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 19, 2015	K142597	Vienna System	JAQ	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.	accessdata.fda.gov
January 20, 2015	K142838	Synapse Occipital-Cervical-Thoracic (OCT) System	NKG	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
October 1, 2014	K142460	EXPEDIUM Spine System/Synapse System	KWP	Substantially Equivalent	Johnson and Johnson	accessdata.fda.gov
September 25, 2014	K141897	SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM	KWP	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
August 29, 2014	K141796	DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
August 22, 2014	K141509	ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS	PGM	Substantially Equivalent	Medos Sarl	accessdata.fda.gov
May 2, 2014	K133616	MATRIXRIB FIXATION SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 28, 2014	K131548	SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
January 16, 2014	K133698	SYNAPSE SYSTEM	KWP	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
January 6, 2014	K131276	LATERAL SYNFIX	OVD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
December 16, 2013	K131792	SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY	GXQ	Substantially Equivalent	Synthes, Inc.	accessdata.fda.gov
October 8, 2013	K131186	SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 20, 2013	K130877	EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 24, 2013	K122639	SYNTHES SYNCAGE EVOLUTION SPACER	MAX	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
May 20, 2013	K130146	SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM	NDN	Substantially Equivalent	Synthes (Usa), LLC	accessdata.fda.gov
April 11, 2013	K122455	SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM	KTT	Substantially Equivalent	Synthes	accessdata.fda.gov
December 17, 2012	K122211	SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS	HAW	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
December 7, 2012	K122861	XTOOL	HRX	Substantially Equivalent	Ouroboros Medical	accessdata.fda.gov
October 19, 2012	K121876	VERTECEM II CEMENT KIT	NDN	Substantially Equivalent	Aap Biomaterials GmbH	accessdata.fda.gov
August 23, 2012	K121502	SYNTHES CURVILINEAR DISTRACTION SYSTEM	MQN	Substantially Equivalent	Synthes, Inc.	accessdata.fda.gov
July 25, 2012	K121852	SYNTHES ZERO-P VARIABLE ANGLE (VA)	OVE	Substantially Equivalent	Synthes Spine Co.Lp	accessdata.fda.gov
July 6, 2012	K121601	SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
July 6, 2012	K120807	SYNTHES MULTILOC HUMERAL NAILING SYSTEM	HSB	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
June 18, 2012	K120854	SYNTHES VA LCP ANKLE TRAUMA SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
June 14, 2012	K111136	EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM	NKB	Unknown	Depuy Spine, Inc.	accessdata.fda.gov
June 4, 2012	K120689	SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
May 18, 2012	K120928	SYNTHES MATRIX SYSTEM	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
May 8, 2012	K120717	SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
May 3, 2012	K121020	VIPER SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
March 21, 2012	K120070	SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
February 29, 2012	K113364	2.7MM LCP ULNA OSTEOTOMY SYSTEM	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 8, 2012	K120083	SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)	HSB	Substantially Equivalent	Synthes USA	accessdata.fda.gov
February 1, 2012	K113149	SYNTHES USS CONNECTORS	MNI	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
January 9, 2012	K113071	SYNTHECEL DURA REPLACEMENT DEVICES	GXQ	Substantially Equivalent	Synthes	accessdata.fda.gov
December 21, 2011	K113251	SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES	JEY	Substantially Equivalent	Synthes, Inc.	accessdata.fda.gov
December 21, 2011	K113044	SYNTHES MIRS	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
December 13, 2011	K110604	VBB SYSTEM	NDN	Substantially Equivalent	Synthes	accessdata.fda.gov
December 12, 2011	K112459	SYNTHES ZERO-P	OVE	Substantially Equivalent	Synthes Spine Co.Lp	accessdata.fda.gov
December 5, 2011	K112583	SYNTHES CORTICAL SCREWS	HWC	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
December 5, 2011	K111667	SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS	JDS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
November 17, 2011	K112085	SYNTHES LCP PEDIATRIC PLATE SYSTEMS	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
November 7, 2011	K112068	SYNTHES ZERO-P VARIABLE ANGLE (VA)	OVE	Substantially Equivalent	Synthes Spine Co.Lp	accessdata.fda.gov
October 26, 2011	K110551	EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Johnson & Johnson	accessdata.fda.gov
October 20, 2011	K103320	SYNTHES XRL	MQP	Substantially Equivalent	Synthes Spine Co.Lp	accessdata.fda.gov
August 8, 2011	K111540	SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
July 28, 2011	K110789	SYNTHES STERNAL ZIPFIX SYSTEM	JDQ	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
July 6, 2011	K111571	VIPER SYSTEMS	NKB	Substantially Equivalent	Johnson & Johnson	accessdata.fda.gov
April 21, 2011	K110125	2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM	HRS	Substantially Equivalent	Synthes USA	accessdata.fda.gov
April 7, 2011	K110353	MOUNTAINEER OCT SPINAL SYSTEM	KWP	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
March 4, 2011	K110354	4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM	JDP	Substantially Equivalent	Synthes USA	accessdata.fda.gov
March 2, 2011	K103002	SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM	HSB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
February 23, 2011	K103128	CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,	ETN	Substantially Equivalent	Cadwell Lab, Inc.	accessdata.fda.gov
January 21, 2011	K103243	2.4MM VA-LCP INTERCARPAL FUSION SYSTEM	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
January 5, 2011	K103287	SYNTHES 6.0 COCR AND CPT TI-3 RODS	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
December 20, 2010	K093762	SYNTHES ZERO-P	OVE	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
December 9, 2010	K102694	2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
December 7, 2010	K101993	VIPER SYSTEM, EXPEDIUM SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
November 15, 2010	K101762	VIPER F2 FACET FIXATION SYSTEM	MRW	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
October 20, 2010	K102701	VIPER SPINE SYSTEM	NKB	Substantially Equivalent	Depuy Spine, Inc.	accessdata.fda.gov
August 31, 2010	K101070	EXPEDIUM SPINE SYSTEM	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 5, 2010	K100952	MODIFICATION TO SYNTHES MATRIX SYSTEM	NKB	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
August 3, 2010	K100776	SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM	HRS	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
July 1, 2010	K100634	SYNTHES MATRIX SYSTEM	NKB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov
May 13, 2010	K100089	SYNTHES T-PAL SPACER	MAX	Substantially Equivalent	Synthes Spine	accessdata.fda.gov
April 14, 2010	K093361	SYNTHES AIR PEN DRIVE (APD) SYSTEM	HBB	Substantially Equivalent	Synthes (Usa)	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 2, 1999	P960025	BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS	MAX	11	March 17, 2004	accessdata.fda.gov

Compare with other makers

Updated June 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.