BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZIMMER MANUFACTURING B.V.

    Reg #: 2648920 · FEI: 1000132037 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    23

    Registration Details

    Registration Name
    ZIMMER MANUFACTURING B.V.
    Registration Number
    2648920
    FEI Number
    1000132037
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROUTE 1, KM. 123.4, BLDG. 2, TURPEAUX INDUSTRIAL PARK
    City
    MERCEDITA
    State
    PR
    ZIP
    00715
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002960

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Cement Obturator LZN
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Template HWT
    Lavage, Jet FQH
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG

    Proprietary Names

    Trilogy Acet Sys Large Head Liner Mutiple Non-Sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers Gamma System Alpha System CPT Stainless Steel Hip VerSys Cemented Revision/Calcar ZULS 2.7mm Locking Plates and Screw (Ti-6Al-4V Alloy, CP Grade Titanium Zimmer Persona Personalized Knee System-Kinematic Alignment Non-Sterile ZPS Compression,Reconstruction, Symphseal Plates and Forte Screws Trilogy Acetabular System Zimmer Plates and Screws System-Screws only Sterile Intermedics Bone Screw HGP Total Hip CO-CR-MO Alloy Femoral Heritage Hip System Trilogy Acetabular Comp. 7mm Offset Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Pulsavac tip with shield Pulsavac tip with filter Pulsavac Tips Pulsavac Plus Wound Debridement System Pulsavac Power supply Pulsavac Splash Shields Pulsavac Plus Low Pressure Wound Debridement Systems Pulsavac Connectors Pulsavac Plus AC Wound Debridement System Zimmer Periarticular Screws Zimmer Plates and Screws (ZPS)-Sterile 2.7mm Cortical Screws Zimmer Periarticular Plating System Z ULS 3.5mm Locking Plates and Scre Beta Hip Prosthesis Zimmer Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System Zimmer Knee Joint Replacement Prosthesis MR Labeling Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Trilogy Acet. Shell & Liners 36mm Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer Plates and Screws System (ZPS) Non-sterile Plates and Screws Zimmer Persona Personalized Knee System ZCA All-Poly Acetabular Cups Bipolar Hip Device G7 ACETABULAR SYSTEM-LTF Zimmer Design Control Trilogy Acetabular Sys, 46mm Large Zimmer Plates and Screws System (ZPS)-Non-sterile ZPS Trilogy Longevity Crosslinked Poly 3.5MM PLATES AND SCREWS-4936 PLATES Universal Locking Sys, 3.5mm Pl & S 4835 SCREWS

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)