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

    CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM

    K Number: K940631 · Decision Jul 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    7
    Review Days
    514

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    Basic Information

    Device Name
    CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
    K Number
    K940631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cross Medical Products, Inc.
    Date Received
    February 14, 1994
    Decision Date
    July 13, 1995
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Cross Medical Products, Inc.

    K Number Device Name
    K974749 SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
    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
    K924381 PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
    K920116 PWB LUMBOSACRAL SPINE SYSTEM
    K895587 CROSS MEDICAL PRODUCT PEDICLE AWL