K250921

Substantially Equivalent

CORIOGRAPH Pre-Op Planning and Modeling Services

Applicant: Blue Belt Technologies, Inc.
Product code: PBF
Advisory panel: Orthopedic
Date received: 2025-03-27
Decision date: 2025-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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.