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510(k) K153770

OS2(R)-VP Varisation Staple by In2bones Sas — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2016
Date Received
December 30, 2015
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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