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

    LSF HA COATED FEMORAL HIP

    K Number: K915617 · Decision May 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    13
    Review Days
    164

    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
    LSF HA COATED FEMORAL HIP
    K Number
    K915617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Technology, Inc.
    Date Received
    December 16, 1991
    Decision Date
    May 28, 1992
    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 Implant Technology, Inc.

    K Number Device Name
    K921525 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
    K920021 LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
    K913616 LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
    K902727 LSF CEMENTED FEMORAL HIP
    K901460 LSF(TM) TOTAL HIP SYSTEM
    K891472 IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
    K884432 MODIFIED LSF TOTAL HIP SYSTEM
    K883212 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
    K855017 LSF* TOTAL HIP SYSTEM
    K841546 COMMUNI-TRACH TUBE
    Search all 13 clearances from Implant Technology, Inc. →