Stable-L Standalone Lumbar Interbody System
FDA 510(k) K212498 · Nexus Spine, LLC
510(k) numberK212498
Submission
- Device name
- Stable-L Standalone Lumbar Interbody System
- Applicant
- Nexus Spine, LLC
Salt Lake City, UT, US - Received
- August 9, 2021
- Decision date
- March 18, 2022
- 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 |
|---|---|---|
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | 06/22/2026SE |
| K253331 | PressON Spinal Fixation SystemNKB · Special | 10/14/2025SE |
| K243934 | Stable-L Lumbar Interbody SystemOVD · Traditional | 04/30/2025SE |
| K241467 | Stable-C Interbody SystemOVE · Traditional | 07/17/2024SE |
| K233375 | Tranquil-L Interbody SystemMAX · Special | 03/20/2024SE |
| K240416 | Tranquil-C Interbody SystemODP · Special | 03/12/2024SE |
| K233234 | PressON Spinal Fixation SystemNKB · Special | 10/26/2023SE |
| K231486 | Stable-L Standalone Lumbar Interbody SystemOVD · Traditional | 10/12/2023SE |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD · Special | 09/18/2023SE |
| K231763 | Stable-C Interbody SystemOVE · Traditional | 08/21/2023SE |
Questions and answers
When was Stable-L Standalone Lumbar Interbody System cleared by the FDA?
Stable-L Standalone Lumbar Interbody System (K212498) received a 510(k) decision of Substantially Equivalent on March 18, 2022, 221 days after the submission was received.
What is the product code of K212498?
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.