Flex-Thread Fibula Pin System— 510(k) K172943

Substantially Equivalent

Intrafuse, LLC

FDA 510(k) clearance K172943 for Flex-Thread Fibula Pin System, Substantially Equivalent on 2017-10-30. Applicant: Intrafuse, LLC.

Clearance details

Applicant: Intrafuse, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2017-09-26
Decision date: 2017-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.