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510(k) Data Aggregation
K Number
K200834Device Name
Lever Action Plate System
Manufacturer
Date Cleared
2020-06-25
(87 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
McGinley Orthpaedic Innovations, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lever Action Plate System is indicated for:
1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion
Device Description
The Lever Action Plate System is a distal radius plate implanted in the treatment of distal radius fractures, non-unions, or osteotomies. The system consists of the plates, screws, beams, beam screws and instrumentation. The plates have either 1 or 2 beam slots which allow for implantation of the beams into the distal radius bone. The beams and their supporting beam screws are intended for maintaining volar correction intra-operatively. The plate and beam(s) are used in conjunction with screws and beam screws to fixate fragments in the wrist. The implants are composed of Ti-6Al-4V and are available in multiple configurations and sizes.
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