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510(k) Data Aggregation
K Number
K140875Device Name
OPTOSSOL COMPRESSION DEVICE SYSTEM
Manufacturer
Date Cleared
2014-05-30
(56 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
GENOSSIS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
Device Description
The GenOssis OptOssol™ Compression Device System implants consists of screws designed to compact juxtaposed bone fragments in compression to enhance bone healing and fusion through the immobilization of the fragments with or without the use of bone graft. The wires are inserted using standard wire drivers present in the operating room and compression is conducted using the provided driver. The partially threaded Wires are available with a Sleeve, and in various diameters and lengths to accommodate patient anatomy.
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