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510(k) K210360

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) by Osteonic Co., Ltd. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
February 8, 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 Osteonic Co., Ltd.

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  • K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (December 3, 2024)
  • K230546 — SIGNEX (June 11, 2024)
  • K233659 — Suture Wing (December 26, 2023)
  • K231322 — Fix2Lock(PEEK Self Punching) (June 7, 2023)
  • K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (May 31, 2023)
  • K211992 — Ortho MI System (October 15, 2021)
  • K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (August 27, 2021)

Other clearances for product code GWO

  • K250297 — TECHFIT Patient-Specific Cranial System (October 27, 2025)
  • K250334 — Fusion Craniofacial Implant; Fusion Skull Implant (July 25, 2025)
  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • K212391 — MCI-Neuro Fixation System (October 21, 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)
  • K183352 — Optimus Neuro System (January 2, 2019)
  • K182425 — Universal Mesh - Sterile (November 6, 2018)