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510(k) K250334

Fusion Craniofacial Implant; Fusion Skull Implant by Kelyniam Global, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2025
Date Received
February 5, 2025
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 Kelyniam Global, Inc.

  • K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)
  • K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI) (September 25, 2012)
  • K103582 — KELYNIAM CUSTOM SKULL IMPLANT (CSI) (April 14, 2011)

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)
  • K183352 — Optimus Neuro System (January 2, 2019)
  • K182425 — Universal Mesh - Sterile (November 6, 2018)