Visualif Challenging Access Plate
FDA 510(k) K122168 · Spine Smith Partners L.P.
510(k) numberK122168
Submission
- Device name
- Visualif Challenging Access Plate
- Applicant
- Spine Smith Partners L.P.
Austin, TX, US - Received
- July 23, 2012
- Decision date
- October 11, 2012
- 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 |
|---|---|---|
| K122630 | IN:C2 Spinal Fixation SystemOVE · Special | 12/05/2012SE |
| K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special | 09/30/2010SE |
| K101085 | Spinesmith Cynch Spinal SystemMAX · Special | 07/01/2010SE |
| K090376 | Spinesmith Cynch Spinal SystemMAX · Traditional | 04/01/2009SE |
| K082821 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2008SE |
| K081132 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 07/14/2008SE |
| K080971 | Spinesmith Cimplicity Spinal SystemMQP · Traditional | 07/02/2008SE |
| K073320 | Cimplicity Spinal SystemODP · Traditional | 02/07/2008SE |
Questions and answers
When was Visualif Challenging Access Plate cleared by the FDA?
Visualif Challenging Access Plate (K122168) received a 510(k) decision of Substantially Equivalent on October 11, 2012, 80 days after the submission was received.
What is the product code of K122168?
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.