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510(k) K212391

MCI-Neuro Fixation System by Mci Medical Concept Innovation, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2022
Date Received
August 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

Other clearances by Mci Medical Concept Innovation, Inc.

  • K182758 — MCI - CMF System (December 5, 2019)

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  • K203055 — Stryker PEEK Customized Cranial Implant Kit (February 9, 2021)
  • K190811 — Optimus NEURO System - Sterile Kit (November 27, 2019)
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  • K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)
  • K183352 — Optimus Neuro System (January 2, 2019)
  • K182425 — Universal Mesh - Sterile (November 6, 2018)