ZSAlign Cervical Interbody System
FDA 510(k) K261451 · ZSFab, Inc.
510(k) numberK261451
Submission
- Device name
- ZSAlign Cervical Interbody System
- Applicant
- ZSFab, Inc.
Waltham, MA, US - Received
- May 1, 2026
- Decision date
- July 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer)OVE · Special | Globus Medical, Inc. | 12/22/2025SE |
More from Globus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | 04/24/2026SE |
| K252610 | ZSFab Lumbar Interbody SystemMAX · Special | 11/25/2025SE |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemODP · Traditional | 11/07/2024SE |
| K232150 | ZSFab Cervical Interbody SystemODP · Special | 08/18/2023SE |
| K221858 | ZSFab Lumbar Interbody SystemMAX · Traditional | 10/14/2022SE |
| K202488 | ZSFab Cervical Interbody SystemODP · Traditional | 01/07/2021SE |
Questions and answers
When was ZSAlign Cervical Interbody System cleared by the FDA?
ZSAlign Cervical Interbody System (K261451) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 91 days after the submission was received.
What is the product code of K261451?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.