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

    PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS

    K Number: K924381 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    7
    Review Days
    260

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    Basic Information

    Device Name
    PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
    K Number
    K924381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cross Medical Products, Inc.
    Date Received
    August 31, 1992
    Decision Date
    May 18, 1993
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Cross Medical Products, Inc.

    K Number Device Name
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    K973836 SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
    K950709 SYNERGY TI ANTERIOR SPINAL SYSTEM
    K940631 CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
    K920116 PWB LUMBOSACRAL SPINE SYSTEM
    K895587 CROSS MEDICAL PRODUCT PEDICLE AWL