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

    DISTALLY FIXED HIP STEM

    K Number: K971523 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    45
    Review Days
    156

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DISTALLY FIXED HIP STEM
    K Number
    K971523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sulzer Orthopedics, Inc.
    Date Received
    April 28, 1997
    Decision Date
    October 1, 1997
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

    Similar 510(k) Clearances

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

    Allure Hip Stem and Intramedullary Plugs

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mfinity Femoral System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trivicta® Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Resolve Modular Revision Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alteon® HA Femoral Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    World Liner

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

    Other Clearances by Sulzer Orthopedics, Inc.

    K Number Device Name
    K022985 ASCENDENT ACETABULAR SYSTEM
    K021578 NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
    K020713 MS-30 LATERAL FEMORAL STEM
    K013935 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
    K013031 MOST OPTIONS SYSTEM
    K012739 CONVERGE ACETABULAR SYSTEM
    K012961 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
    K011954 SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
    K010839 CLS VARUS STEM/CLS 135 STEM
    K003758 ALLOFIT ACETABULAR SYSTEM
    Search all 45 clearances from Sulzer Orthopedics, Inc. →