510(k) K132624

TRIATHLON TRITANIUM METAL-BACKED PATELLA by Stryker Orthopaedics — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2013
Date Received
August 22, 2013
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