TRIATHLON TRITANIUM METAL-BACKED PATELLA
FDA 510(k) clearance K132624 · decided 2013-11-26
Clearance details
- K-number
- K132624
- Device name
- TRIATHLON TRITANIUM METAL-BACKED PATELLA
- Applicant
- Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2013-08-22
- Decision date
- 2013-11-26
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Kn recall (Z-1379-2021) | Howmedica Osteonics Corp. | 2021-04-09 |