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510(k) K180022

Athena Cervical Plate System by Medyssey USA, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2018
Date Received
January 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K170389 — TAURUS PEEK Cage System (December 14, 2017)
  • K172756 — Varian cage (December 8, 2017)
  • K170341 — Medussa-PL Cage (November 2, 2017)

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