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510(k) K172157

DePuy Synthes Femoral Recon Nail System by Synthes (USA) Products, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2017
Date Received
July 18, 2017
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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