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510(k) K131061

RESTORE BUNION CORRECTION SYSTEM by Nextremity Solutions — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2013
Date Received
April 16, 2013
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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