KINEMAX TIBIAL WEDGE— 510(k) K884837

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K884837 for KINEMAX TIBIAL WEDGE, Substantially Equivalent on 1989-02-17. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 1988-11-18
Decision date: 1989-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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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.