TRIATHLON PKR SYSTEM— 510(k) K071881

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K071881 for TRIATHLON PKR SYSTEM, Substantially Equivalent on 2007-10-09. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2007-07-09
Decision date: 2007-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, 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.