TRIDENT CONSTRAINED ACETABULAR INSERT— 510(k) K061654

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K061654 for TRIDENT CONSTRAINED ACETABULAR INSERT, Substantially Equivalent on 2006-07-07. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2006-06-13
Decision date: 2006-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, US

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Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.