Bolo Button System— 510(k) K242091

Substantially Equivalent

Fusion Orthopedics

FDA 510(k) clearance K242091 for Bolo Button System, Substantially Equivalent on 2024-12-23. Applicant: Fusion Orthopedics.

Clearance details

Applicant: Fusion Orthopedics
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2024-07-17
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesa, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.