BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Zimmer Biomet Canada DFE

    Reg #: 3012392319 · FEI: 3012392319 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    20

    Registration Details

    Registration Name
    Zimmer Biomet Canada DFE
    Registration Number
    3012392319
    FEI Number
    3012392319
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2323 Argentia Road
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K142933
    PMA Number
    P010014

    Owner / Operator

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

    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, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing NRA
    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, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Rod, Fixation, Intramedullary And Accessories HSB
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG

    Proprietary Names

    Biomet Tibial Trays VANGUARD 360 REVISION KNEE SYSTEM LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA TAPERLOC COMPLETE, SIZE 5 AND 6 X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL MALLORY-HEAD TOTAL HIP SYSTEM REACH HIP COMPONENT UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM Inter-Op Acetabular Sys.-Dursul Ace MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS TAPERLOC COMPLETE SIZE 4MM AND XR 123 INTEGRAL CO-CR FEMORAL COMPONENT VANGUARD XP KNEE SYSTEM VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT

    Establishment Types

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