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510(k) K182711

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) by Kelyniam Global, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2019
Date Received
September 27, 2018
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.

  • K250334 — Fusion Craniofacial Implant; Fusion Skull Implant (July 25, 2025)
  • 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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  • 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)
  • 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)
  • K183352 — Optimus Neuro System (January 2, 2019)
  • K182425 — Universal Mesh - Sterile (November 6, 2018)