BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LINK MP Monoblock Hip Prosthesis

    K Number: K183141 · Decision Feb 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    284
    Registration Numbers
    284
    Same Product Code
    522
    Applicant Total
    25
    Review Days
    87

    Basic Information

    Device Name
    LINK MP Monoblock Hip Prosthesis
    K Number
    K183141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    November 13, 2018
    Decision Date
    February 8, 2019
    Product Code
    LZO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.

    RECLAIM Monobloc Revision Femoral Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MobileLink Acetabular Cup System - inhouse coatings

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXUS® Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Origin™ Cemented Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zimmer Biomet Ceramic Heads (22.2mm diameter)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATALYSTEM Femoral Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Waldemar Link GmbH & Co. KG

    K Number Device Name
    K241636 MobileLink Acetabular Cup System - Line Extension (Multiple)
    K231445 LINK Embrace Shoulder System - Reverse Configuration
    K230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
    K213770 SP-CL Hip Stem and LCU Hip System
    K221794 Vario-Cup System
    K211567 BiMobile Instruments (for BiMobile Dual Mobility System)
    K220628 LINK Endo-Model EVO Knee System
    K212992 LINK® Embrace Shoulder System - Reverse Configuration
    K212742 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
    K211768 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
    Search all 25 clearances from Waldemar Link GmbH & Co. KG →