BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Zimmer Orthopedic Mfg Ltd

    Reg #: 3007963827 · FEI: 3007963827 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    Zimmer Orthopedic Mfg Ltd
    Registration Number
    3007963827
    FEI Number
    3007963827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building No 2 East Park, Shannon Industrial Estate
    City
    Shannon Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K023211
    PMA Number
    P060037

    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, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing NRA
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL

    Proprietary Names

    NexGen Cruciate Retaining VANGUARD 360 REVISION KNEE SYSTEM OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Persona Partial Knee System Zimmer Knee Joint Replacement Prosthesis MR Labeling NexGen Gender Sol. Female (GSF) Fem Zimmer Persona TM Femorals Zimmer Persona Personalized Knee System Zimmer Persona Personalized Knee System-Kinematic Alignment Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Next Generation Knee System NexGen Legacy Posterior Stabilized NexGen LPS-Flex Mobile Bearing Knee Persona Knee System-CPS

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)