510(k) K151983

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

K151983 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin LSS Plating System". The FDA issued a decision of Substantially Equivalent on April 6, 2016. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. KLS Martin L.P. has at least 10 other 510(k) clearances on record.

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