BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Zimmer Biomet Taiwan Co., Ltd.

    Reg #: 3011683674 · FEI: 3011683674 · Expires 2026
    View on FDA
    Products
    108
    Proprietary Names
    62
    Establishment Types
    1
    Classifications
    108

    Registration Details

    Registration Name
    Zimmer Biomet Taiwan Co., Ltd.
    Registration Number
    3011683674
    FEI Number
    3011683674
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7F., No. 35, Ln. 11, Guangfu N. Rd.,Songshan Dist.,
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K960535
    PMA Number
    N17755

    Owner / Operator

    Firm Name
    Zimmer Biomet APAC DFE
    Operator Number
    10056128
    Address
    Unit 01-10,19/F, Metro Plaza 555 Lou Shan Guan Road, Changning District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200051
    Country
    CN

    US Agent

    Business Name
    ZIMMER BIOMET
    Contact Name
    STEPHANIE LYNCH
    Address
    1800 W Center St
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    715 9289253

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Bone Cement LOD
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Cerclage, Fixation JDQ
    Screw, Fixation, Bone HWC
    Rod, Fixation, Intramedullary And Accessories HSB
    Pin, Fixation, Smooth HTY
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Elbow, Constrained, Cemented JDC
    Skid, Bone HWO
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Sterilizer, Chemical MLR
    Holder, Needle; Orthopedic HXK
    Arthroscope HRX
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Pin, Fixation, Threaded JDW
    Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal KWB
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Semi-Constrained, Composite/Metal KMC
    Nail, Fixation, Bone JDS
    Impactor HWA
    Staple, Fixation, Bone JDR
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Prosthesis, Toe, Constrained, Polymer KWH
    Neurological Stereotaxic Instrument HAW
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Sterilizer, Steam FLE
    Washer, Bolt Nut HTN
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Filler, Bone Void, Calcium Compound MQV
    Cement Obturator LZN
    Tourniquet, Pneumatic KCY
    Bender HXW
    Device, Fixation, Proximal Femoral, Implant JDO
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Gauze/Sponge, Internal EFQ
    Curette HTF
    Component, Traction, Invasive JEC
    Hook, Surgical, General & Plastic Surgery GDG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Nail, Fixation, Bone, Metallic NDH
    Plate, Fixation, Bone, Non-Spinal, Metallic NDF
    File HTP
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Orthopedic Stereotaxic Instrument OLO
    Gouge, Surgical, General & Plastic Surgery GDH
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Spinal Vertebral Body Replacement Device MQP
    Syringe, Piston FMF
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Bone Cement, Antibiotic MBB
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Lavage, Jet FQH
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Forceps, Wire Holding HYA
    Pliers, Surgical HTC
    Laparoscope, General & Plastic Surgery GCJ
    Caliper KTZ
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Tape, Measuring, Rulers And Calipers FTY
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Retention Device, Suture KGS
    Saw HSO
    Applier, Cerclage HXN
    Forceps HTD
    Osteotome HWM
    Clip, Implantable FZP
    Marker, Radiographic, Implantable NEU
    Gauge, Depth HTJ
    Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer NJD
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Expander, Surgical, Skin Graft FZW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Mixer, Cement, For Clinical Use JDZ
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented MJT
    Rongeur HTX

    Proprietary Names

    ALLthread™ Titanium Suture Anchor A. L. P. S. Clavicle Plating System Zimmer Comprehensive Shoulder System Taperloc Complete, Sizes 5mm and 6mm Prolong Highly Crosslinked Poly Cru XR-Series Bi-Metric® Femoral Components Taper 2™ Porous Femoral Stem BIOMET IMPACTOR QuattroTm Link Knotless Anchor Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM Biomet Modular Femoral Revision System Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Comprehensive Humeral Fracture Biolox® delta Option Ceramic Heads BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS Comprehensive® Primary Shoulder Stems VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT Dual Port/Single Bladder Disposable Cuff BENDER Pioneer ZCS Cannulated Screw System by Pionee Curette CuffLinkTm Suture Anchor HOOK, SURGICAL, GENERAL & PLASTIC SURGERY Vanguard 360 Revision Knee System Titanium Interference Screws BIOMET FILE ToggleLocTM System Vanguard XP Knee System NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM TaperLoc Complete Pulsavac Plus THE NATURAL-KNEE REVISION Orthopedic Salvage System - OSS Zimmer NexGen Tibial and Femoral Augments PLIERS, SURGICAL CALIPER Persona Partial Knee System TAPE, MEASURING, RULERS AND CALIPERS Biomet Variable Pitch Compression Screw System Bi-Metric CoCr Head/Neck Replacement Hip Stems AFX® Femoral Implant with Inserter FORCEPS BIOMET OSTEOTOME Lateralized Taperloc® Microplasty™ Femoral Components ANA0TOMICAL SHOULDER TM COMBINED SYSTEM INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM BIOMET DEPTH; GAUGE; Gauge Biomet Depth ROSA® Knee System LORENZ PECTUS SUPPORT BAR STABILIZER Taperloc Complete Microplasty System MeshGraft II X-SERIES BI-METRIC HIP FEMORAL COMPONENTS G7 Acetabular System MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL Biomet Knee Joint Replacement Prostheses BIOMET CEMENT; MIXER Comprehensive® Reverse Shoulder Taperloc Complete Size 4mm and XR 123 RONGUER; STRAIGHT

    Establishment Types

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