S2 TIBIAL NAIL— 510(k) K022481

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K022481 for S2 TIBIAL NAIL, Substantially Equivalent on 2002-08-26. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2002-07-29
Decision date: 2002-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.