510(k) K143049

LYNC intramedullary implant by Novastep — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2015
Date Received
October 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type