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510(k) K231834

VSP PEEK Cranial Implant by 3D Systems, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
June 22, 2023
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 3D Systems, Inc.

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  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K241326 — Cadence Ankle PSI System (August 30, 2024)
  • K241148 — Salto Talaris Ankle PSI System (August 30, 2024)
  • K231585 — Vantage PSI System (June 30, 2023)
  • K214093 — VSP Bolus (March 30, 2022)
  • K211244 — VSP® Orthopedics System (November 10, 2021)
  • K210347 — VSP System (April 26, 2021)
  • K193432 — Vantage PSI System (November 9, 2020)

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)
  • 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)