aprevo® anterior lumbar interbody fusion device with interfixation
FDA 510(k) K243635 · Carlsmed, Inc.
510(k) numberK243635
Submission
- Device name
- aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc.
Carlsbad, CA, US - Received
- November 25, 2024
- Decision date
- December 13, 2024
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…MAX · Traditional | 05/09/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | 04/22/2026SE |
| K252894 | aprevo® cervical interbody systemODP · Traditional | 01/06/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | 12/22/2025SE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…MAX · Traditional | 07/07/2025SE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion deviceMAX · Traditional | 06/30/2025SE |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…OVD · Traditional | 03/17/2025SE |
| K242599 | aprevo® Digital PlanningLLZ · Traditional | 12/20/2024SE |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMODP · Traditional | 11/15/2024SE |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Traditional | 10/09/2024SE |
Questions and answers
When was aprevo® anterior lumbar interbody fusion device with interfixation cleared by the FDA?
aprevo® anterior lumbar interbody fusion device with interfixation (K243635) received a 510(k) decision of Substantially Equivalent on December 13, 2024, 18 days after the submission was received.
What is the product code of K243635?
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.