BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Zimmer Orthopedics Manufacturing Limited-Galway

    Reg #: 3012319330 · FEI: 3012319330 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    Zimmer Orthopedics Manufacturing Limited-Galway
    Registration Number
    3012319330
    FEI Number
    3012319330
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Deerpark Industrial Estate
    City
    Oranmore Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K150090

    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, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI

    Proprietary Names

    COMPREHENSIVE PRIMARY SHOULDER STEMS Comprehensive Shoulder System Persona Partial Knee System Zimmer Persona Personalized Knee System-Medial Congruent Persona™ Personalized Knee System Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Zimmer Persona Knee System Persona OsseoTi 3-Peg Patella Persona Natural Tibia Baseplates Size J and Instrumentation Persona Knee System-CPS Persona Partial Knee Persona Personalized Knee System-PPS Zimmer Persona Personalized Knee System-Kinematic Alignment Persona the Personalized Knee System Zimmer Persona Personalized Knee System G7 OSSEOTI ACETUBLAR SHELLS G7 ACETABULAR SYSTEM-LTF Zimmer Design Control

    Establishment Types

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