Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts— 510(k) K180612
Substantially EquivalentHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA 510(k) clearance K180612 for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts, Substantially Equivalent on 2018-06-07. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.
Clearance details
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Product code
- Code HSX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
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.