BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm

    Reg #: 1818910 · FEI: 1818910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    172
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    DEPUY ORTHOPAEDICS, INC.
    Registration Number
    1818910
    FEI Number
    1818910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 ORTHOPAEDIC DR.
    City
    WARSAW
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    PMA Number
    P830055

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL

    Proprietary Names

    ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm ATTUNE REVISION RP STEM ADAPTOR TRIAL ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm ATTUNE REVISION RP BASE TRIAL SIZE 7 ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM ATTUNE Revision Tibial Sleeve 29 mm Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm ATTUNE REVISION RP BASE TRIAL SIZE 4 ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm ATTUNE REVISION RP BASE TRIAL SIZE 8 ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm ATTUNE REVISION RP BASE TRIAL SIZE 6 ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm ATTUNE REVISION RP BASE TRIAL SIZE 9 ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm ATTUNE REVISION RP BASE TRIAL SIZE 10 ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM TRUMATCH Personalized Solutions ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm ATTUNE REVISION RP BASE TRIAL SIZE 3 ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm ATTUNE REVISION RP BASE TRIAL SIZE 5 ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm ATTUNE REVISION RP BASE TRIAL SIZE 2 ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM ATTUNE® Revision Knee System LCS, New Jersey Total Knee

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device