510(k) K112675

ARROW-LOK DIGITAL SYSTEM by Arrowhead Medical Device Technologies, LLC — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2011
Date Received
September 14, 2011
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