BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    ZIMMER PTE. LTD.

    Reg #: 3013176080 · FEI: 3013176080 · Expires 2026
    View on FDA
    Products
    82
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    82

    Registration Details

    Registration Name
    ZIMMER PTE. LTD.
    Registration Number
    3013176080
    FEI Number
    3013176080
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    401 Commonwealth Drive #06-03, How Par Techno Centre
    City
    Singapore South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K083364
    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 West Center Street Warsaw, IN US 46580
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    715 9289253

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Component, Traction, Invasive JEC
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented MJT
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Cerclage, Fixation JDQ
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Syringe, Piston FMF
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Nail, Fixation, Bone, Metallic NDH
    Plate, Fixation, Bone, Non-Spinal, Metallic NDF
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Clip, Implantable FZP
    Marker, Radiographic, Implantable NEU
    Arthroscope HRX
    Pin, Fixation, Threaded JDW
    Washer, Bolt Nut HTN
    Pin, Fixation, Smooth HTY
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Elbow, Constrained, Cemented JDC
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Nail, Fixation, Bone JDS
    Staple, Fixation, Bone JDR
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Laparoscope, General & Plastic Surgery GCJ
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Neurological Stereotaxic Instrument HAW
    Device, Fixation, Proximal Femoral, Implant JDO
    Bone Cement LOD
    Gauze/Sponge, Internal EFQ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Filler, Bone Void, Calcium Compound MQV
    Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer NJD
    Holder, Needle; Orthopedic HXK
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Cement Obturator LZN
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Retention Device, Suture KGS
    Prosthesis, Hip, Semi-Constrained, Composite/Metal KMC
    Sterilizer, Steam FLE
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Prosthesis, Toe, Constrained, Polymer KWH
    Bone Cement, Antibiotic MBB
    Applier, Cerclage HXN
    Sterilizer, Chemical MLR

    Proprietary Names

    Biomet Knee Joint Replacement Prostheses THE NATURAL-KNEE REVISION

    Establishment Types

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