STRYKER TRAUMA PELVIC SET— 510(k) K001614

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K001614 for STRYKER TRAUMA PELVIC SET, Substantially Equivalent on 2000-08-04. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 2000-05-25
Decision date: 2000-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.