Acu-Sinch Knotless Mini
FDA 510(k)Class II (US FDA 510(k))
by Acumed, LLC
Identifiers
- 510(k) Number
- K243624 FDA 510(k)
- FDA Product Code
- HTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acu-Sinch Knotless Mini is a device designed for anatomically challenging, smaller repairs in soft tissue fixation. It is intended to maximize strength while minimizing complexity in surgical procedures.
The device is supplied as a system for use in orthopedic settings, supporting fast procedures and predictable outcomes. It has received FDA 510(k) clearance under K243624 and is classified under product code HTN.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Acu-Sinch® Knotless Mini System - info.acumed.net, PDF Acu-Sinch® Knotless Mini System - acumed.net, AcuSinch Knotless Mini Surgical Technique with Jerry Huang, MD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243624 | Class II | Active |
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Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K243624 24 fields · synced Sep 22, 2026