BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Accolade Hip System

    Reg #: 3013014058 · FEI: 3013014058 · Expires 2025
    View on FDA
    Products
    17
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    Stryker Anngrove
    Registration Number
    3013014058
    FEI Number
    3013014058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Anngrove Building, IDA Business & Technology Park, Carrigtwohill
    City
    Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K233498

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Screw, Fixation, Bone HWC
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Wire, Surgical LRN
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Cement Obturator LZN
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Fixation Accessory LYT

    Proprietary Names

    Accolade Hip System Universal Cement Spacer OmniFit Hip System Trident II Acetabular System MDM Acetabular Liner Trident Acetabular System C-Taper Femoral Heads ADM MDM Insert Anato Hip Stem Unitrax V40 Head Restoration Modular Hip Stem System UHR BiPolar Unitrax Sleeve SecurFit Hip System Gap II Shell Universal Adaptor Sleeve Tritanium Acetabular Shells Dall Miles Cable System Exeter X3 RimFit All Poly Cup Insignia Hip Stem Restoration Anatomic Acetabular Shell Osteolock Screws Restoration Acetabular Augments V40 Femoral Heads Exeter Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)