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510(k) K190811

Optimus NEURO System - Sterile Kit by Osteonic Co., Ltd. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2019
Date Received
March 29, 2019
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

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  • K190229 — Stryker PEEK Customized Cranial Implant Kit (July 11, 2019)
  • 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)