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

    ASCENSION PYROCARBON LUNATE

    K Number: K080997 · Decision Jun 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    22
    Review Days
    70

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    Basic Information

    Device Name
    ASCENSION PYROCARBON LUNATE
    K Number
    K080997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3750
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics, Inc.
    Date Received
    April 8, 2008
    Decision Date
    June 17, 2008
    Product Code
    KWN
    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
    KWN Prosthesis, Wrist, Carpal Lunate

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    Other Clearances by Ascension Orthopedics, Inc.

    K Number Device Name
    K233674 Freedom Wrist Arthroplasty System
    K233670 Ascension Silicone MCP; Ascension Silicone PIP
    K121826 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
    K110700 ASCENSION ATLAS HUMERAL PLATING SYSTEM
    K102549 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
    K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM
    K100502 ASCENSION TOTAL PLATE SYSTEM
    K100925 ASCENSION ANKLE FUSION NAIL SYSTEM
    K100176 ASCENSION ANKLE FUSION PLATE SYSTEM
    K092047 ASCENSION METAL GREAT TOE SYSTEM
    Search all 22 clearances from Ascension Orthopedics, Inc. →