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510(k) Data Aggregation
K Number
K250092Device Name
HC Biologics Osteopoint Spinal Fixation System
Manufacturer
HC Biologics LLC
Date Cleared
2025-03-27
(72 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why 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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