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510(k) Data Aggregation
K Number
K211628Device Name
MIS Precision Chevron Bunion System
Manufacturer
Date Cleared
2022-01-31
(249 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
RELJA Innovations, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Device Description
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
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