Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device System
FDA 510(k) K131880 · Spinefrontier, Inc.
510(k) numberK131880
Submission
- Device name
- Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device System
- Applicant
- Spinefrontier, Inc.
Colorado Springs, CO, US - Received
- June 25, 2013
- Decision date
- January 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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.
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| 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 |
|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Special | 06/19/2020SE |
| K172484 | A-CIFT SoloFuseOVE · Traditional | 05/08/2018SE |
| K151198 | A-CIFT SoloFuseOVE · Special | 07/17/2015SE |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR · Traditional | 04/24/2015SE |
| K143377 | PedFuse Pedicle Screw SystemMNH · Special | 02/12/2015SE |
| K141333 | Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceODP · Traditional | 11/25/2014SE |
| K142026 | Spinefrontier Arena-C Ha PEEK Cervical Intervertebral Body Fusion DeviceODP · Traditional | 10/20/2014SE |
| K141337 | Arena-CODP · Traditional | 09/08/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | 05/14/2014SE |
Questions and answers
When was Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device System cleared by the FDA?
Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device System (K131880) received a 510(k) decision of Substantially Equivalent on January 3, 2014, 192 days after the submission was received.
What is the product code of K131880?
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.