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510(k) K161254

Renovo Life Small Bone IM Nail System by Renovo Life, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2016
Date Received
May 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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