Acu-Sinch Knotless Mini— 510(k) K243624

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K243624 for Acu-Sinch Knotless Mini, Substantially Equivalent on 2025-01-23. Applicant: Acumed, LLC.

Clearance details

Applicant: Acumed, LLC
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2024-11-25
Decision date: 2025-01-23
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.