Spine Wave Anterior Cervical Spine System
FDA 510(k) K162760 · Spine Wave, Inc.
510(k) numberK162760
Submission
- Device name
- Spine Wave Anterior Cervical Spine System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- September 30, 2016
- Decision date
- February 16, 2017
- 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | 05/29/2026SE |
| K243816 | Testa TP Pivoting Spacer SystemMAX · Traditional | 06/27/2025SE |
| K251131 | Annex® 2 Adjacent Level SystemNKB · Traditional | 06/06/2025SE |
| K243514 | Salvo® Robotic Navigation InstrumentsOLO · Traditional | 04/03/2025SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | 05/06/2024SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
| K222362 | Salvo® Spine SystemNKB · Special | 08/29/2022SE |
| K202476 | Salvo® Spine SystemNKB · Traditional | 11/05/2020SE |
| K192526 | Spine Wave Navigated InstrumentsOLO · Special | 10/10/2019SE |
Questions and answers
When was Spine Wave Anterior Cervical Spine System cleared by the FDA?
Spine Wave Anterior Cervical Spine System (K162760) received a 510(k) decision of Substantially Equivalent on February 16, 2017, 139 days after the submission was received.
What is the product code of K162760?
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.