E3D-A Interbody System
FDA 510(k) K232432 · Evolution Spine
510(k) numberK232432
Submission
- Device name
- E3D-A Interbody System
- Applicant
- Evolution Spine
Dallas, TX, US - Received
- August 11, 2023
- Decision date
- January 30, 2024
- 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 |
|---|---|---|
| K262094 | E3D-C Interbody SystemOVE · Special | 07/22/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | 02/04/2026SE |
| K250167 | Evolution Spine Navigation InstrumentsOLO · Traditional | 08/18/2025SE |
| K241846 | E3D-C Interbody SystemOVE · Traditional | 08/12/2024SE |
| K240368 | E3D-A Interbody SystemOVD · Traditional | 05/15/2024SE |
| K223146 | EVOLUTION SPINE Interbody SystemOVD · Traditional | 02/07/2023SE |
| K220275 | EMERGE Anterior Cervical Plate SystemKWQ · Traditional | 03/18/2022SE |
| K212405 | EMERGE Anterior Cervical Plate SystemKWQ · Abbreviated | 09/30/2021SE |
| K182478 | Whistler Modular Pedicle Screw SystemNKB · Traditional | 01/15/2019SE |
| K180755 | Vail ALIF Buttress Plate SystemKWQ · Traditional | 07/06/2018SE |
Questions and answers
When was E3D-A Interbody System cleared by the FDA?
E3D-A Interbody System (K232432) received a 510(k) decision of Substantially Equivalent on January 30, 2024, 172 days after the submission was received.
What is the product code of K232432?
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.