K220717

Substantially Equivalent

RedPoint Medical's Better Bunion System

Applicant: Redpoint Medical, LLC
Product code: PBF
Advisory panel: Orthopedic
Date received: 2022-03-11
Decision date: 2022-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, 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.