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510(k) K261058

CraniUS Plate by CraniUS, LLC — Product Code GWO

K261058 is an FDA 510(k) premarket notification submitted by CraniUS, LLC for the device "CraniUS Plate". The FDA issued a decision of Substantially Equivalent on July 29, 2026. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2026
Date Received
March 31, 2026
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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  • 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)

FDA data resources