K231278

Substantially Equivalent

Knotless Suture Anchor

Applicant: Riverpoint Medical, LLC
Product code: MBI
Advisory panel: Orthopedic
Date received: 2023-05-03
Decision date: 2023-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.