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

    ASST-3000 SPINAL SURGERY TABLE

    K Number: K883457 · Decision Aug 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    95
    Review Days
    14

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    Basic Information

    Device Name
    ASST-3000 SPINAL SURGERY TABLE
    K Number
    K883457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Orthopedic Systems, Inc.
    Date Received
    August 12, 1988
    Decision Date
    August 26, 1988
    Product Code
    FWY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FWY Table, Operating-Room, Non-Electrical

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    Other Clearances by Orthopedic Systems, Inc.

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    K910031 PARK CITY SHOULDER POSITIONER
    K903938 C FIT CUP
    K892503 NUFFIELD TOTAL KNEE
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    K894283 COMPREHENSIVE SPINE MOTION ANALYZER
    K890498 FREEMAN MODULAR HIP STEM RIDGED VERSION
    K890331 FREEMAN TOTAL HIP SYSTEM RIDGED STEM
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