TransLoc 3D— 510(k) K232878

Substantially Equivalent

Foundation Fusion Solutions, LLC (Dba Cornerloc)

FDA 510(k) clearance K232878 for TransLoc 3D, Substantially Equivalent on 2023-10-17. Applicant: Foundation Fusion Solutions, LLC (Dba Cornerloc).

Clearance details

Applicant: Foundation Fusion Solutions, LLC (Dba Cornerloc)
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2023-09-18
Decision date: 2023-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.