Genesys Spine 3DP Cervical Interbody System
FDA 510(k) K191489 · Genesys Spine
510(k) numberK191489
Submission
- Device name
- Genesys Spine 3DP Cervical Interbody System
- Applicant
- Genesys Spine
Austin, TX, US - Received
- June 4, 2019
- Decision date
- January 8, 2020
- 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 |
|---|---|---|
| K252322 | SIros-X SystemOUR · Traditional | 10/22/2025SE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE · Traditional | 02/07/2025SE |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with NavigationOLO · Traditional | 03/29/2024SE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE · Special | 12/13/2023SE |
| K220096 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Special | 03/09/2022SE |
| K182987 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Traditional | 12/12/2019SE |
| K192678 | Genesys Spine Binary® Lumbar Plate SystemKWQ · Special | 10/24/2019SE |
| K191748 | Genesys Spine Sacroiliac Joint Fusion SystemOUR · Traditional | 09/26/2019SE |
| K192076 | Binary® Anterior Cervical Plate SystemKWQ · Special | 08/29/2019SE |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone SystemOVE · Traditional | 08/29/2018SE |
Questions and answers
When was Genesys Spine 3DP Cervical Interbody System cleared by the FDA?
Genesys Spine 3DP Cervical Interbody System (K191489) received a 510(k) decision of Substantially Equivalent on January 8, 2020, 218 days after the submission was received.
What is the product code of K191489?
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.