Acumed Small Bone IM Nail System— 510(k) K143276

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K143276 for Acumed Small Bone IM Nail System, Substantially Equivalent on 2015-02-05. Applicant: Acumed, LLC.

Clearance details

Applicant: Acumed, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2014-11-14
Decision date: 2015-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, 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.