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510(k) K112837

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) by Vilex, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2012
Date Received
September 28, 2011
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

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