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510(k) Data Aggregation

    K Number
    K031654
    Device Name
    SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2003-08-08

    (72 days)

    Product Code
    GXR
    Regulation Number
    882.5250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps.

    Device Description

    Synthes Resorbable Cranial Clamp consists of two disks connected by a tensioned ratcheting shaft. The clamps fit a range of burr holes and craniotomy gap sizes.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that evaluates the performance of the "Synthes Resorbable Cranial Clamp, (modified)". The document is a 510(k) summary and an FDA clearance letter, which describe the device's intended use, classification, and substantial equivalence to predicate devices, but do not contain detailed study results or performance metrics in relation to acceptance criteria.

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