Cleared Traditional

TECHFIT Patient-Specific Cranial System

K250297 · Techfit Digital Surgery, Inc. · Neurology
Oct 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K250297 is an FDA 510(k) clearance for the TECHFIT Patient-Specific Cranial System, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Techfit Digital Surgery, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on October 27, 2025, 269 days after receiving the submission on January 31, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K250297 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date October 27, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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