Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment— 510(k) K190991
Substantially EquivalentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)
FDA 510(k) clearance K190991 for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment, Substantially Equivalent on 2019-08-15. Applicant: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics).
Clearance details
- Applicant
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
- Product code
- Code MBH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . 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.