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510(k) Data Aggregation

    K Number
    K250092
    Device Name
    HC Biologics Osteopoint Spinal Fixation System
    Manufacturer
    HC Biologics LLC
    Date Cleared
    2025-03-27

    (72 days)

    Product Code
    NKB, KWP
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    HC Biologics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HC Biologics Osteopoint Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: -Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), -Spondylolisthesis. - -Trauma (i.e., fracture or dislocation), -Spinal stenosis, - -Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). -Tumor, - -Pseudoarthrosis, and/or -Failed previous fusion
    Device Description
    HC Biologics Osteopoint Spinal Fixation System is top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.
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