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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Relja Innovations, LLC. It received FDA 510(k) clearance on 2022-01-31 under 510(k) 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. The listed applicant is Relja Innovations, LLC. The 510(k) number is K211628.

When did MIS Precision Chevron Bunion System receive FDA 510(k) clearance?

MIS Precision Chevron Bunion System received FDA 510(k) clearance on 2022-01-31, under 510(k) number K211628.

Who is the listed applicant for MIS Precision Chevron Bunion System?

The FDA 510(k) record lists Relja Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Relja Innovations, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262075Lapidus Screw Kit

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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