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510(k) Data Aggregation
K Number
K203408Device Name
Summit Patella Plating System
Manufacturer
Date Cleared
2021-07-30
(253 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Endeavor Orthopaedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Summit Patella Plating System is indicated for use in surgical stabilization of patella fractures during open reduction internal fixation (ORIF) procedures in adults. Each system includes a plate, screws, surgical suture, and instruments that are provided in a sterile procedure kit and intended for single use.
Device Description
The Endeavor Orthopaedics Summit Patella Plating System is a plating system used for fixation of patella fractures. The system includes implants and ancillary instruments needed for open reduction internal fixation (ORIF) of a patella fracture, packaged together in a single use sterile procedure kit. The kit provides a patella plate, locking screws, nonabsorbable sutures with needles and surgical instrumentation required for preparation of fracture fragments, manipulation/reduction of the patella, provisional fixation, plate placement and definitive fixation to the dorsal surface of the patella. The system is intended for single use, by a licensed orthopedic surgeon.
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