MIS Precision Chevron Bunion System— 510(k) K211628

Substantially Equivalent

Relja Innovations, LLC

FDA 510(k) clearance K211628 for MIS Precision Chevron Bunion System, Substantially Equivalent on 2022-01-31. Applicant: Relja Innovations, LLC.

Clearance details

Applicant: Relja Innovations, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2021-05-27
Decision date: 2022-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookfield, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.