Atlas Spine Lateral Expandable Interbody System
FDA 510(k) K243191 · Atlas Spine, Inc.
510(k) numberK243191
Submission
- Device name
- Atlas Spine Lateral Expandable Interbody System
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- September 30, 2024
- Decision date
- November 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | 11/10/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | 08/15/2025SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | 10/30/2020SE |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemOVE · Traditional | 02/28/2020SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | 11/29/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | 06/13/2018SE |
| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
| K162918 | Atlas Spine Expandable Interbody SystemMAX · Traditional | 02/09/2017SE |
| K112759 | Apclo Pedicle Screw SystemsNKB · Special | 10/18/2011SE |
Questions and answers
When was Atlas Spine Lateral Expandable Interbody System cleared by the FDA?
Atlas Spine Lateral Expandable Interbody System (K243191) received a 510(k) decision of Substantially Equivalent on November 26, 2024, 57 days after the submission was received.
What is the product code of K243191?
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.