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

    CROSS MEDICAL PRODUCT PEDICLE AWL

    K Number: K895587 · Decision Jan 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    325
    Registration Numbers
    325
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    111

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    Basic Information

    Device Name
    CROSS MEDICAL PRODUCT PEDICLE AWL
    K Number
    K895587
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Cross Medical Products, Inc.
    Date Received
    September 15, 1989
    Decision Date
    January 4, 1990
    Product Code
    HWJ
    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
    HWJ Awl

    Similar 510(k) Clearances

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    ACROMED WALLIE-HEINIG TROCHAR

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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
    K924381 PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
    K920116 PWB LUMBOSACRAL SPINE SYSTEM