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

    ORTHOMET LHMC FEMORAL STEM

    K Number: K931678 · Decision Oct 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    60
    Review Days
    556

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    Basic Information

    Device Name
    ORTHOMET LHMC FEMORAL STEM
    K Number
    K931678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1510
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthomet, Inc.
    Date Received
    April 6, 1993
    Decision Date
    October 14, 1994
    Product Code
    HMC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HMC Monitor, Eye Movement, Diagnostic

    Other Clearances by Orthomet, Inc.

    K Number Device Name
    K936310 ORTHOMET HMC FEMORAL STEM COMPONENT
    K945783 ORTHOMET TITANIUM HYBRID FEMORAL STEM
    K943873 ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
    K944752 ORTHOMET RESURFACING FEMORAL COMPONENT
    K930771 PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
    K926334 AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
    K932677 AXIOM TOTAL KNEE SYSTEM
    K931333 ORTHOMET ACETABULAR CUP SYSTEM
    K923243 PERFECTA TOTAL HIP SYSTEM
    K925536 HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
    Search all 60 clearances from Orthomet, Inc. →