510(k) K153204

In2Bones Kirschner wire by In2bones Sas — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2016
Date Received
November 4, 2015
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