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510(k) Data Aggregation

    K Number
    K043334
    Device Name
    BONE SOURCE HAC RAPID SETTING CEMENT
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    2005-02-09

    (68 days)

    Product Code
    GXP,FWP
    Regulation Number
    882.5300
    Type
    Special
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K032366
    Why did this record match?
    Device Name :

    BONE SOURCE HAC RAPID SETTING CEMENT

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

    BoneSource® HAC Rapid Setting Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

    Device Description

    BoneSource® HAC Rapid Setting Cement is a self-setting, calcium phosphate cement.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (BoneSource® HAC Rapid Setting Cement) and the FDA's clearance letter. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document states that the device is "substantially equivalent" to a predicate device (BoneSource® HAC (K032366)). This means that for a 510(k) submission, the manufacturer showed that their new device is as safe and effective as a legally marketed device, not that they performed a de novo study to establish new acceptance criteria and then met them.

    Therefore, I cannot provide the requested information from the given input.

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