Akros Fibulink Syndesmosis Repair Kit— 510(k) K162805

Substantially Equivalent

Akros Medical

FDA 510(k) clearance K162805 for Akros Fibulink Syndesmosis Repair Kit, Substantially Equivalent on 2017-01-10. Applicant: Akros Medical.

Clearance details

Applicant: Akros Medical
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2016-10-05
Decision date: 2017-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.