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510(k) K183352

Optimus Neuro System by Osteonic Co., Ltd. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2019
Date Received
December 3, 2018
Clearance Type
Special
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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  • K231322 — Fix2Lock(PEEK Self Punching) (June 7, 2023)
  • K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (May 31, 2023)
  • K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu (January 27, 2022)
  • K211992 — Ortho MI System (October 15, 2021)

Other clearances for product code GWO

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  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • K212391 — MCI-Neuro Fixation System (October 21, 2022)
  • K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu (January 27, 2022)
  • K203055 — Stryker PEEK Customized Cranial Implant Kit (February 9, 2021)
  • K190811 — Optimus NEURO System - Sterile Kit (November 27, 2019)
  • K190229 — Stryker PEEK Customized Cranial Implant Kit (July 11, 2019)
  • K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)
  • K182425 — Universal Mesh - Sterile (November 6, 2018)