Anterior Spine Truss System-Stand Alone (ASTS-SA)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233966 FDA 510(k)
- FDA Product Code
- OVD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Anterior Spine Truss System-Stand Alone (ASTS-SA) is an orthopedic device designed for spinal stabilization. It is intended for use in anterior spinal fusion procedures to provide structural support and promote bone fusion.
The device is supplied non-sterile and is intended for single-use. It is used in hospital or surgical center settings by trained medical professionals. The ASTS-SA has received FDA 510(k) clearance under product code OVD, with K-number K233966, and is authorized for marketing in the United States.
Frequently asked questions
What is the Anterior Spine Truss System-Stand Alone (ASTS-SA) used for?
The ASTS-SA is an orthopedic device designed for spinal stabilization and is intended for use in anterior spinal fusion procedures to provide structural support and promote bone fusion.
How is the ASTS-SA supplied and is it reusable?
The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after a procedure.
Who is authorized to use the ASTS-SA and where is it used?
The ASTS-SA is used in hospital or surgical center settings by trained medical professionals performing anterior spinal fusion procedures.
What regulatory pathway was used for the ASTS-SA and what is its K-number?
The ASTS-SA received FDA 510(k) clearance under product code OVD, with K-number K233966, and is authorized for marketing in the United States.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233966 | Class II | Active |
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Manufacturer
- Manufacturer
- 4Web Medical, Inc.
Sources (1)
- FDA 510(k) K233966 24 fields · synced Sep 21, 2026