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

    OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS

    K Number: K930187 · Decision Mar 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    178
    Review Days
    413

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    Basic Information

    Device Name
    OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
    K Number
    K930187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteonics Corp.
    Date Received
    January 14, 1993
    Decision Date
    March 3, 1994
    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

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    Other Clearances by Osteonics Corp.

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    K982798 OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
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    K990203 OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
    K990158 OSTEONICS COMBINATION SCREW RING/BLOCKER
    K984302 OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
    K984353 OSTEO 9MM IC TIBIAL NAIL
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