Vault Alif System
FDA 510(k) K130445 · Spinal USA
510(k) numberK130445
Submission
- Device name
- Vault Alif System
- Applicant
- Spinal USA
Round Rock, TX, US - Received
- February 21, 2013
- Decision date
- April 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K132029 | Vault-C Intervertebral Body Fusion DeviceOVE · Traditional | 11/25/2013SE |
| K130863 | Facet Screw SystemMRW · Traditional | 08/09/2013SE |
| K131343 | Reform Pedicle Screw SystemMNI · Traditional | 07/24/2013SE |
| K130279 | Reform Pedicle Screw SystemMNI · Traditional | 06/20/2013SE |
| K122931 | S-Lok PSS SystemMNI · Traditional | 11/20/2012SE |
| K121172 | Reform Pedicle Screw SystemMNI · Special | 08/08/2012SE |
| K112748 | Slimplicity Solo Anterior Cervical Plate SystemKWQ · Traditional | 07/11/2012SE |
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Traditional | 09/15/2011SE |
| K103369 | Vault Alif SystemOVD · Traditional | 04/04/2011SE |
| K092659 | Spinal USA RCS Anterior Lumbar Butress Plate System, Model 22-1001-25KWQ · Traditional | 11/17/2009SE |
Questions and answers
When was Vault Alif System cleared by the FDA?
Vault Alif System (K130445) received a 510(k) decision of Substantially Equivalent on April 25, 2013, 63 days after the submission was received.
What is the product code of K130445?
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.