510(k) K132945

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL by I.T.S. GmbH — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2014
Date Received
September 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type