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510(k) Data Aggregation

    K Number
    K991398
    Device Name
    BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
    Manufacturer
    STRYKER LEIBINGER
    Date Cleared
    1999-09-22

    (153 days)

    Product Code
    GXP,FWP
    Regulation Number
    882.5300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K953339,K864537,K970400,K973789
    Why did this record match?
    Device Name :

    BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

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

    The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair The Donesourgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface or nourcement but notes) e defect. BoneSource is also indicated for augmentation or arestoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.

    Device Description

    The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previouslycleared BoneSource hydroxyapatite cement powder along with a new prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are being provided in sizes ranging from 5 g to 50 g.

    AI/ML Overview

    The provided text is related to the 510(k) submission for BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document states:

    • Proprietary Name: BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit
    • Common Name: Hydroxyapatite Cement (HAC)
    • Intended Use: Repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects, and augmentation/restoration of bony contour in the craniofacial skeleton (fronto-orbital, malar, mental areas).
    • Predicate Device: BoneSource Hydroxyapatite Cement (K953339, K864537 and K970400) and Norian® CRS™ Craniofacial Repair System (K973789).
    • Device Description: It's an expanded kit containing previously cleared BoneSource hydroxyapatite cement powder, a new prefilled syringe with sodium phosphate solution, and a mixing spatula.

    The 510(k) summary only describes the device and its intended uses, and asserts substantial equivalence to predicate devices. It does not include details on performance testing, acceptance criteria, or specific studies that demonstrate the device meets any performance criteria. Therefore, I cannot generate the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement.

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