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510(k) Data Aggregation
K Number
K130019Device Name
J-SCREW COMPRESSION SCREW
Manufacturer
Date Cleared
2014-11-18
(684 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
COMPETITIVE ENGINEERING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.
Device Description
The J-Screw is a two part bone screw for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities. The unique design of the device allows it to fixate or fuse small bones with infinitely adjustable fusing compression, in a fixed yet flexed position.
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