Uni Knee Resurfacing System— 510(k) K221292

Substantially Equivalent

Overture Resurfacing, Inc.

FDA 510(k) clearance K221292 for Uni Knee Resurfacing System, Substantially Equivalent on 2023-03-10. Applicant: Overture Resurfacing, Inc..

Clearance details

Applicant: Overture Resurfacing, Inc.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2022-05-04
Decision date: 2023-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.