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510(k) Data Aggregation

    K Number
    K243190
    Device Name
    USTOMED Bone Fixation/Bone Augmentation Systems - PIN
    Manufacturer
    Ustomed Instrumente Ulrich Storz GmbH & Co. KG
    Date Cleared
    2025-06-27

    (270 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Ustomed Instrumente Ulrich Storz GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.
    Device Description
    USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently. The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.
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