MIS Precision Chevron Bunion System
K-Number: K211628 · 2022-01-31
ApplicantRelja Innovations, LLC
Decision Date2022-01-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MIS Precision Chevron Bunion System is a medical device manufactured by Relja Innovations, LLC. It received FDA 510(k) clearance on 2022-01-31 under approval number K211628. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MIS Precision Chevron Bunion System?
MIS Precision Chevron Bunion System is a medical device that received FDA 510(k) clearance on 2022-01-31. It is manufactured by Relja Innovations, LLC. The 510(k) number is K211628.
When was MIS Precision Chevron Bunion System approved by the FDA?
MIS Precision Chevron Bunion System received FDA 510(k) clearance on 2022-01-31, under approval number K211628.
What company makes MIS Precision Chevron Bunion System?
MIS Precision Chevron Bunion System is manufactured by Relja Innovations, LLC.
What is the FDA product code for MIS Precision Chevron Bunion System?
The FDA product code for MIS Precision Chevron Bunion System is HWC. This falls under the Cardiovascular category.
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Official Source
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