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510(k) Data Aggregation

    K Number
    K251556
    Device Name
    Device 300423 Granules
    Manufacturer
    Geistlich Pharma AG
    Date Cleared
    2025-07-17

    (57 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K241802
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Device 300423 Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300423 Granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

    Device 300423 Granules must be used with blood or autogenous bone marrow aspirate and autograft in posterolateral spine.

    Device Description

    Device 300423 Granules is an osteoconductive, dry, porous, resorbable bone graft substitute which consists of calcium phosphate granules of proprietary alpha-tricalcium phosphate (α-TCP) and hydroxyapatite (HAp). The single-patient, single-use product is supplied sterile (via X-ray irradiation) as 0.25-1 or 0.8-2 mm granules packaged in 6 mL glass vials. The glass vials containing Device 300423 Granules are individually packaged in A-PET blisters and sealed with polyethylene (HDPE) Tyvek film.

    AI/ML Overview

    N/A

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