OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP— 510(k) K911373

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K911373 for OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP, Substantially Equivalent on 1991-06-26. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 1991-03-28
Decision date: 1991-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.