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510(k) Data Aggregation
K Number
K200259Device Name
Headless Compression Screw System
Manufacturer
Date Cleared
2020-05-04
(91 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
OsteoCentric Extremities, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.
The screw fasteners are intended for single use only and may not be reused under any circumstances.
The system drills and guide wires are single use instruments.
Device Description
The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.
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