510(k) K111970

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT by Tornier — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2012
Date Received
July 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type