SERIES II CONSTRAINED ACETABULAR LINERS— 510(k) K063552

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K063552 for SERIES II CONSTRAINED ACETABULAR LINERS, Substantially Equivalent on 2007-03-08. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2006-11-24
Decision date: 2007-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.