510(k) K143323

OS2-V Varisation Staple by In2bones Sas — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2015
Date Received
November 19, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type