aprevo® cervical interbody system
FDA 510(k) K252894 · Carlsmed, Inc.
510(k) numberK252894
Submission
- Device name
- aprevo® cervical interbody system
- Applicant
- Carlsmed, Inc.
Carlsbad, CA, US - Received
- September 11, 2025
- Decision date
- January 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 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 |
| 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 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Special | 12/13/2024SE |
| 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® cervical interbody system cleared by the FDA?
aprevo® cervical interbody system (K252894) received a 510(k) decision of Substantially Equivalent on January 6, 2026, 117 days after the submission was received.
What is the product code of K252894?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.