BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SYNTHES GMBH / Synthes Produktions GmbH

    Reg #: 8030965 · FEI: 3002807305 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    35
    Establishment Types
    2
    Classifications
    27

    Registration Details

    Registration Name
    SYNTHES GMBH / Synthes Produktions GmbH
    Registration Number
    8030965
    FEI Number
    3002807305
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    EIMATTSTRASSE 3
    City
    Oberdorf, Baselland Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K141385

    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
    Fastener, Plate, Cranioplasty HBW
    Pin, Fixation, Smooth HTY
    Staple, Fixation, Bone JDR
    Cover, Burr Hole GXR
    Rod, Fixation, Intramedullary And Accessories HSB
    Screwdriver HXX
    Syringe, Piston FMF
    Methyl Methacrylate For Cranioplasty GXP
    Plate, Bone JEY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Bone Cement LOD
    Battery, Replacement, Rechargeable MOQ
    Driver, Wire, And Bone Drill, Manual DZJ
    Drill, Bone, Powered DZI
    Driver, Surgical, Pin GFC
    Motor, Drill, Pneumatic HBB
    Motor, Surgical Instrument, Ac-Powered GEY
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Tray, Surgical, Instrument FSM
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Filler, Bone Void, Calcium Compound MQV
    Orthopedic Manual Surgical Instrument LXH
    Bone Grafting Material, Synthetic LYC
    Guide, Surgical, Instrument FZX

    Proprietary Names

    DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) HAMMERLOCK 2 Staple, fixation, bone SYNTHES (USA) RAPID RESORBABLE CRAN DePuy Synthes Femoral Recon Nail System screwdriver DePuy Synthes Hammertoe Continuous Compression Implant Synthes Angular Stable Locking System Synthes Angular Stable Locking Syst syringe SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM SYNTHES POLY (L-LACTIDE-CO-GLYCOLID Irrigation clips instrument TRAUMACEM" V+ Injectable Bone Cement Speed, Speed Shift, Speed Titan, Speed Arc VARIOUS RECHARGEABLE BATTERIES Synthes 90 Degree Screwdriver TORQUE LIMITING ATTACHMENT SPEED SHIFT SPEED TRIAD Synthes Air Pen Drive System VARIOUS BATTERY POWE KINCISE Orthomesh SPEED XL SYNTHES (USA) ELECTRIC PEN DRIVE SY tray blade FILLER, BONE VOID, CALCIUM COMPOUND surgical instrument bone grafting material filler guide SPEED ARC

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility