Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
FDA 510(k) K200002 · 4Web, Inc.
510(k) numberK200002
Submission
- Device name
- Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
- Applicant
- 4Web, Inc.
Frisco, TX, US - Received
- January 2, 2020
- Decision date
- May 29, 2020
- 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 |
|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 02/12/2026SE |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ · Traditional | 03/10/2021SE |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA)OVE · Traditional | 08/12/2019SE |
| K190926 | Hammertoe Truss System (HTS)HTY · Traditional | 07/23/2019SE |
| K172294 | Osteotomy Truss System (OTS)HRS · Traditional | 02/22/2018SE |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/08/2018SE |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX · Traditional | 11/07/2017SE |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX · Traditional | 09/08/2017SE |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX · Traditional | 08/07/2017SE |
| K153436 | LATERAL Spine Truss SystemMAX · Traditional | 06/06/2016SE |
Questions and answers
When was Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device cleared by the FDA?
Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) received a 510(k) decision of Substantially Equivalent on May 29, 2020, 148 days after the submission was received.
What is the product code of K200002?
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.