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510(k) K182991

EPIC Extremity Fusion Plate System by Epic Extremity, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2019
Date Received
October 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Epic Extremity, LLC

  • K172441 — EPIC Extremity Fracture Plate System (November 6, 2017)
  • K163038 — EPIC Extremity Snap-Off Screw (February 28, 2017)
  • K153340 — Epic Extremity Plate System (February 9, 2016)
  • K153333 — Epic Extremity Cannulated Screw System (January 19, 2016)

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