510(k) K141056
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS by
Stryker Orthopaedics
— Product Code MBH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2014
- Date Received
- April 24, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type