TECHFIT Patient-Specific Cranial System— 510(k) K250297

Substantially Equivalent

Techfit Digital Surgery, Inc.

FDA 510(k) clearance K250297 for TECHFIT Patient-Specific Cranial System, Substantially Equivalent on 2025-10-27. Applicant: Techfit Digital Surgery, Inc..

Clearance details

Applicant: Techfit Digital Surgery, Inc.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2025-01-31
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daytona Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.