Interwedge® Standalone Lateral
FDA 510(k) K261809 · Foundation Surgical Group
510(k) numberK261809
Submission
- Device name
- Interwedge® Standalone Lateral
- Applicant
- Foundation Surgical Group
Scottsdale, AZ, US - Received
- June 1, 2026
- Decision date
- July 31, 2026
- 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 |
| 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 |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Avalign Technologies, Inc. | 07/10/2025SE |
More from Avalign Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | 07/31/2026SE |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep InstrumentsOLO · Traditional | 04/16/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | 11/07/2024SE |
| K241487 | Interwedge® Standalone LateralOVD · Traditional | 10/02/2024SE |
Questions and answers
When was Interwedge® Standalone Lateral cleared by the FDA?
Interwedge® Standalone Lateral (K261809) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 60 days after the submission was received.
What is the product code of K261809?
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.