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510(k) Data Aggregation
K Number
K233567Device Name
OsteoCoil Nitinol Compression System (Multiple Component PNs)
Manufacturer
Flower Orthopedics Corporation DBA Conventus Flower Ortho
Date Cleared
2024-11-22
(382 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Flower Orthopedics Corporation DBA Conventus Flower Ortho
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.
Device Description
This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).
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