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