Anterior Spine Truss System-Stand Alone (ASTS-SA)
FDA 510(k) K233966 · 4Web Medical, Inc.
510(k) numberK233966
Submission
- Device name
- Anterior Spine Truss System-Stand Alone (ASTS-SA)
- Applicant
- 4Web Medical, Inc.
Frisco, TX, US - Received
- December 15, 2023
- Decision date
- April 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 01/28/2026SE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE · Traditional | 12/11/2025SE |
| K251117 | Cervical Spine Truss System (CSTS)OVE · Special | 04/25/2025SE |
| K240388 | Osteotomy Truss System (OTS)HRS · Traditional | 11/01/2024SE |
| K230088 | Ankle Truss System (ATS)SAI · Traditional | 03/21/2024SE |
| K231739 | Cervical Spine Truss System (CSTS)OVE · Traditional | 09/25/2023SE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE · Traditional | 02/02/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/05/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 09/06/2022SE |
| K220463 | Osteotomy Truss System (OTS)HRS · Traditional | 05/18/2022SE |
Questions and answers
When was Anterior Spine Truss System-Stand Alone (ASTS-SA) cleared by the FDA?
Anterior Spine Truss System-Stand Alone (ASTS-SA) (K233966) received a 510(k) decision of Substantially Equivalent on April 22, 2024, 129 days after the submission was received.
What is the product code of K233966?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.