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

    SYNERGY TI ANTERIOR SPINAL SYSTEM

    K Number: K950709 · Decision Oct 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    7
    Review Days
    254

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    Basic Information

    Device Name
    SYNERGY TI ANTERIOR SPINAL SYSTEM
    K Number
    K950709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cross Medical Products, Inc.
    Date Received
    February 13, 1995
    Decision Date
    October 25, 1995
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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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
    K940631 CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
    K924381 PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
    K920116 PWB LUMBOSACRAL SPINE SYSTEM
    K895587 CROSS MEDICAL PRODUCT PEDICLE AWL