Fine TTO— 510(k) K250394

Substantially Equivalent

Bodycad Laboratories, Inc.

FDA 510(k) clearance K250394 for Fine TTO, Substantially Equivalent on 2025-10-21. Applicant: Bodycad Laboratories, Inc..

Clearance details

Applicant: Bodycad Laboratories, Inc.
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2025-02-12
Decision date: 2025-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.