510(k) K080434

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW by Smith & Nephew, Inc. — Product Code JDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2008
Date Received
February 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type