Home / 510(k) Clearances / K250297

510(k) K250297

TECHFIT Patient-Specific Cranial System by Techfit Digital Surgery, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2025
Date Received
January 31, 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 Techfit Digital Surgery, Inc.

  • K242263 — TECHFIT DISRP® System (December 11, 2024)
  • K230276 — TECHFIT DISRP® System (June 23, 2023)
  • K222577 — TECHFIT Diagnostic Models (January 6, 2023)
  • K220199 — AFFINITY Proximal Tibia System (March 21, 2022)

Other clearances for product code GWO

  • 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)
  • 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)