BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Zimmer, Inc. Hip Joint Prostheses MR Labeling I

    K Number: K200823 · Decision Jul 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    29
    Review Days
    101

    Basic Information

    Device Name
    Zimmer, Inc. Hip Joint Prostheses MR Labeling I
    K Number
    K200823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    March 30, 2020
    Decision Date
    July 9, 2020
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

    Similar 510(k) Clearances

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

    Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker Orthopaedics Hip Systems Labeling Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C-Stem AMT LE Prosthesis

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

    Other Clearances by Zimmer, Inc.

    K Number Device Name
    K243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
    K241873 OsseoFit Stemless Shoulder System
    K242543 Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
    K243247 Persona the Personalized Knee System
    K240299 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
    K230321 Persona™ Personalized Knee System
    K221479 Persona Personalized Knee System
    K222566 Zimmer Persona Personalized Knee System
    K212512 G7® Vivacit-E® Freedom® Constrained Liner
    K210842 VerSys Cemented Revision/Calcar
    Search all 29 clearances from Zimmer, Inc. →