TRIATHLON TRITANIUM METAL-BACKED PATELLA— 510(k) K132624

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K132624 for TRIATHLON TRITANIUM METAL-BACKED PATELLA, Substantially Equivalent on 2013-11-26. Applicant: Stryker Orthopaedics.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2013-08-22
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.