510(k) K151983

KLS Martin LSS Plating System by KLS Martin L.P. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2016
Date Received
July 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type