HOWMEDICA KINEMATIC II TIBIAL WEDGE— 510(k) K842367

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K842367 for HOWMEDICA KINEMATIC II TIBIAL WEDGE, Substantially Equivalent on 1984-08-17. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 1984-06-15
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.