Acumed Ankle Syndesmosis Repair System— 510(k) K212990

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K212990 for Acumed Ankle Syndesmosis Repair System, Substantially Equivalent on 2022-01-07. Applicant: Acumed, LLC.

Clearance details

Applicant: Acumed, LLC
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2021-09-20
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, 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.