Stabilis SA Cervical Stand-Alone System (Various PNs)
FDA 510(k) K251735 · Acuity Surgical Devices, LLC
510(k) numberK251735
Submission
- Device name
- Stabilis SA Cervical Stand-Alone System (Various PNs)
- Applicant
- Acuity Surgical Devices, LLC
Irving, TX, US - Received
- June 6, 2025
- Decision date
- July 30, 2025
- 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 |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| 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 |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs)MAX · Traditional | 06/02/2025SE |
| K243386 | Ventris Intervertebral Body Fusion DeviceOVD · Traditional | 04/22/2025SE |
| K241413 | sagAlign Lumbar Cage System (Various PNs)MAX · Traditional | 07/17/2024SE |
| K230639 | Align Cervical Interbody Fusion SystemODP · Traditional | 12/01/2023SE |
| K222561 | AlignOVD · Special | 09/23/2022SE |
| K221535 | Align Lumbar Interbody Fusion SystemMAX · Traditional | 07/22/2022SE |
| K201671 | A-Link ZOVD · Traditional | 05/04/2021SE |
Questions and answers
When was Stabilis SA Cervical Stand-Alone System (Various PNs) cleared by the FDA?
Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735) received a 510(k) decision of Substantially Equivalent on July 30, 2025, 54 days after the submission was received.
What is the product code of K251735?
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.