K120262

Substantially Equivalent

HLS UNI EVOLUTION & U-KNEETEC

Applicant: Tornier, Inc.
Product code: HSX
Advisory panel: Orthopedic
Date received: 2012-01-27
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montbonnot, FR

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.