BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPINE-TECH BONE HARVESTER

    K Number: K970040 · Decision Feb 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    4
    Review Days
    53

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    Basic Information

    Device Name
    SPINE-TECH BONE HARVESTER
    K Number
    K970040
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spine-Tech, Inc.
    Date Received
    January 6, 1997
    Decision Date
    February 28, 1997
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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    Other Clearances by Spine-Tech, Inc.

    K Number Device Name
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