BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Synthes GMBH

    Reg #: 3000270450 · FEI: 3000270450 · Expires 2026
    View on FDA
    Products
    90
    Proprietary Names
    311
    Establishment Types
    2
    Classifications
    90

    Registration Details

    Registration Name
    Synthes GMBH
    Registration Number
    3000270450
    FEI Number
    3000270450
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriestrasse 28
    City
    Selzach Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K092473
    PMA Number
    P960025

    Owner / Operator

    Firm Name
    SYNTHES GMBH / Synthes Produktions GmbH
    Operator Number
    9071542
    Address
    1301 Goshen Parkway
    City
    West Chester
    State
    PA
    Postal Code
    19380
    Country
    US

    Products

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

    Proprietary Names

    chisel Expedium Spine System Dispenser, Cement DEPUY SYNTHES MAXFRAME AUTOSTRUT System Synthes MatrixMANDIBLE Preformed Reconstruction Plates SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR Surgical Punch Moss Miami Spine System Synthes 3.5/4.5 Curved Narrow/Broad SYNTHES VECTRA SYSTEM DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM DePuy Synthes Femoral Neck System MATRIXRIB FIXATION SYSTEM Depuy Synthes Variable Angle Locking Hand System - 1.3 mm and 2 mm Plates and Screws Synthes ClampFix System Monarch Spine System Viper F2 Facet Fixation System SYNTHES USS SYNTHES (USA) [SYNTHES] MINI EXTERN SYNTHES STERILE 4.5 MM CANNULATED SCREWS ISOLA Spine System MANDIBLE EXTERNAL FIXATOR TITANIUM (TI) ALLOY HIGH TIBIAL OST TAN Unreamed Femoral Nail Matrix Sagittal Screws Viper System MODULAR FOOT SYSTEM - 2.7 MM MODULE plate DePuy Synthes TFNA Augmentation System SAW EIN End Cap SYNTHES EXTERNAL FIXATION DEVICES, burr SYNTHES SYNEX SPACER SYSTEM SYNTHES 1.5MM/2MM ORTHOGNATHIC MA DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) 3.5/4.5 LCP w/ Expanded Indications 2.4mm Cannulated Screw MAXFRAME Autostrut SynCage Evolution Spacer VSP Spine System SYNTHES (USA) LARGE FRAGMENT LOCKIN SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM Synthes LCP Pediatric Plate System Orthomesh SPIKED WASHER SYNTHES DUAL-OPENING USS SYNFIX-LR Irrigation clips instrument Surgical Titanium Mesh BowTi Anterior Buttress Staple starter SYNTHES AFS Plate fixation, bone nail, fixation, bone Synthes Multiloc Proximal Humeral Nailing System SYNTHES (USA) LCP MODULAR FOOT PLATES ELBOW HINGE FIXATOR SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM SYNTHES (U.S.A.) UNIVERSAL SPINAL P screw Titanium Distal Femoral Nail SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR M-2 Anterior Plate System (Ocelot Stackable Cage System) Viper SAI SYNTHES (USA) CONDYLAR HEAD ADD-ON SYNTHES (USA) CLAVICLE HOOK PLATES Mountaineer OCT Spinal System Synthes 4.5mm VA-LCP Curved Condylar Plate System DHS-Troch Stabilizaiton Plate SYNTHES MINI EXTERNAL FIXATOR SYNTHES ANTERIOR CSLP SYSTEM Zero-P VA Summit SI OCT Spinal Fixation System broach 6.5mm Midfoot Fusion Bolt BIT, DRILL SYNTHES CERVIFIX/ AXON SYNTHES CRANIAL FLAP TUBE CLAMP Suprapatellar Insertion Instruments SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE screwdriver Synthes Curvilinear Distraction System Synthes (USA) VA-LCP 2-Col Narrow DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System Synthes Angular Stable Locking System Synthes Angular Stable Locking Syst SYNTHES ANTERIOR CERVICAL LOCKING P SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM PEAK Anterior Compression Plate System Kaneda SR Anterior System DePuy Synthes Femoral Recon Nail System Vertebroplasty Needle Kit Synthes Air Pen Drive System Condylar Head Add-on-System Synthes2.4 LCP Vol. Col. Dist. Radi 3.5mm Locking Attachment Plates SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIV SYNTHES LCP PROXIMAL HUMERUS PLATES Expedium SFX Cross Connector System 3MM HEADLESS COMPRESSION SCREWS CrossOver Cross Connector Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment TITANIUM CANNULATED TIBIAL NAIL (TI Synthes Zero-P TAMP ZERO-P NATURAL Plate TITANIUM LOCKING PLATE SYSTEM CLICK`X Jaguar Lumbar I/F Cage System Smooth threaded metallic bone fix SYNTHES LCP PROXIMAL TIBIA PLATES L FILLER, BONE VOID, CALCIUM COMPOUND SYNTHES (USA) LCP PROXIMAL HUMERUS Synthes 90 Degree Screwdriver SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) HANDLE, SCALPEL Synthes Sternal ZipFix System SOCKET PUSHER Synthes Graphic Case & Tray System Matrix RIB Fixation System SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM 3.5 MM LCP DISTAL HUMERUS SYSTEM Synthes 6 CoCr and CP Ti-3 Rods SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS Synthes Matrix MIS Rods SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM SYNTHES MODULAR FOOT SYSTEM TOMOFIX OSTEOTOMY SYSTEM crimper 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES TAP Sterile 2.7mm recon Plates rongeur SYNTHES (USA) TIBIAL NAIL SYSTEM EX plate, fixation, bone Posteromedial Proximal Tibia Plate Synthes Synapse 4 System Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins SYNTHES(USA) SYNTHES HYBRID EXTERNA SMALL FRAGMENT DYNAMIC COMPRESSION Synthes Self-Drilling Schanz Screws 4.5 MM AND 6.5 MM HEADLESS COMPRESS guide Surgical Bit SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) Synthes 1.5mm Headless Comp. Screws 2.4mm Variable Angle LCP Volar Rim Distal Radius System DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System SYNTHES VA LCP ANKLE TRAUMA SYSTEM SYNTHES (USA) MODULAR MINI FRAGMENT SYNTHES LOCKING DISTAL RADIUS PLATI Synthes TFN Screw SYNTHES USS (10MM SIDE OPENING SCREWS SYNTHES CURVED RECONSTRUCTION PLATE CrossOver System Pelvic C-Clamp USS Iliosacral and Polyaxial System 3.5mm LCP Hook Plates 3.5 / 4.5 MM LCP METAPHYSEAL PLATES injector dissector SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM HINDFOOT ARTHRODESIS NAIL SYNTHES (USA) 2.4/2.7 MM LOCKING FO SYNTHES XRL SYNTHES (USA) LOW-PROFILE WRIST FIXATOR UNIVERSAL FEMORAL NAIL Profile Anterior Fixation System Synthes ASLS System SYNTHES (USA) CALVICLE HOOK PLATE MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK SYNTHES RECONSTRUCTIVE PLATES `Y` P Synthes Matrix System Synthes Unreamed Humeral Nail MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System countersink SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SLIM-LOC Anterior Cervical Plate System Synthes Oracle Plate Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Anterior ISOLA System Trochanter Stabilization Plate DHS SYNTHES REPROCESSED EXTERNAL FIXATI T-PAL Ti Spacer probe LCP SYNTHES USS, CLICK`X, USS VAS, DUAL SUMMIT Fixation System Small Stature Ant. Cerv. Vertebral MIRS Synthes Neuro Plate and Screw System SYNTHES OC FUSION SYSTEM SYNTHES VECTRA-ONE SYSTEM Synthes Cervifix System Sternal Fixation System SYNTHES USS CONNECTORS CANNULATED FEMORAL NAIL GONIOMETER surgical instrument DYNAMIC HIP SCREW SYNTHES PANGEA SYSTEM ALC Dynamized Fixation System SYNTHES MANDIBLE DISTRACTOR 2.4/2.7mm VA-LCP Forefoot/Midfoot Stimulator, Nerve Synthes 2.7mm LCP Ulna Osteotomy Plate System SYNAPSE SYSTEM SMALL STATURE USS SUMMIT Bone Screw USS VAS TRAUMACEM" V+ Injectable Bone Cement Synthes MatrixMANDIBLE Preformed Re USS-LINE EXTENSION UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM SYNTHECEL DURA REPLACEMENT DEVICES Synthes Self Drilling Schanz Screws SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM Synthes T-PAL Spacer Synapse Occipital-Cervical-Thoracic (OCT) System SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM LCP CURVED PLATES Ankle Trauma System ANGLED BLADE PLATE Synthes Large Ex Fix, MR Cond. SYNTHES UNIVERSAL SPINAL SYSTEM Synthes MultiLoc Humeral Nailing System Synthes Locking Hand Plates CONCORDE Clear MIS Discectomy Device VERTECEM II CEMENT KIT T-PAL SYNTHES LARGE FRAGMENT DYNAMIC COMP MOUNTAINEER Laminoplasty System SYNFIX Lateral 4.5 MM LCP STRAIGHT RECONSTRUCTION 2.4mm Cannulated Compression Screw SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) DePuySynthes Next Generation Hand System 2.4mm VA LCP Two Column Volar DR Spotlight Access System VOLAR DISTAL RADIUS PLATE Set Screw for Ti Trochanteric Fixation Nail (TFN) ANTERIOR CSLP SYSTEM TomoFix Medial High Tibia Pl. Small SYNTHES (USA) 3.5MM CONICAL SCREWS SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM SYNTHES PILON PLATE MODIFICATION TO SYNTHES CERVIFIX SYSTEM VBB System Synapse System, Synthes OC Fusion System EXTRACTOR SYMPHONY OCT System 3.5mm VA LCP Proximal TIbia Plate System reamer SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES STERNAL FIXATION SYSTEM SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM Bengal Stackable Cage System SYNTHES (USA) UNIV SPINE ROD/SACRAL Synthecel Dura Repair, Synthecel Dura Onlay SYNTHES SYNAPSE TRANSCONNECTOR SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM SYNTHES BUTTON PLATE SYNTHES ANTERIOR TENSION BAND (ATB) SYNTHES VECTRA-T SYSTEM SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM tray, surgical SYNTHES STAINLESS STEEL MODULAR HAN SYNTHES SPINE PEDIATRIC ROD SYSTEM Synthes Cortical Screws Synthes Navigable Pedicle Preparation Instruments Titanium TomoFix Medial High Tibia Plate Anatomical SYNTHES SPINE UNIVERSAL SPINAL HOOK SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM TROCHANTERIC FIXATION NAIL (TFN) Vienna System SYNFIX Evolution Synthes Light Guide DePuy Synthes MAXFRAME Multi-Axial Correction System DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long Viper 2 System Cougar System TomoFix Medial Distal Femur Plates SYNTHES LCP DISTAL TIBIA PLATES MatrixORTHOGNATHIC Plating System SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACR ELASTIC INTRAMEDULLARY NAIL (EIN) E MODIFICATION TO SYNTHES MATRIX SYSTEM FRONTIER Anterior Scoliosis System DePuy Synthes MatrixSTERNUM Fixation System HA COATED SCHANZ SCREWS Expedium Anterior Spine System SYNTHES (USA) ALVEOLAR RIDGE DISTRA Kaneda Anterior Scoliosis System driver SS Elastic IM Nail USS Appliance Fix, Nail Blade Plate Com DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System SYNTHES (USA) LATERAL ENTRY FEMORAL Dental Bone Cutting Instruments Synthes (USA) 2.4mm Cortex Screw MINI LENGTHENING APPARATUS SYNFIX-LR SPACER SYNTHES (USA) 2.4 MM LCP WRIST PLATE caliper DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System DePuy Synthes Cortex and Cannulated Screws

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device