Atlas Spine Expandable Cervical Standalone Interbody System
FDA 510(k) K192570 · Atlas Spine, Inc.
510(k) numberK192570
Submission
- Device name
- Atlas Spine Expandable Cervical Standalone Interbody System
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- September 18, 2019
- Decision date
- February 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | 11/10/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | 08/15/2025SE |
| K243191 | Atlas Spine Lateral Expandable Interbody SystemOVD · Traditional | 11/26/2024SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | 10/30/2020SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | 11/29/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | 06/13/2018SE |
| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
| K162918 | Atlas Spine Expandable Interbody SystemMAX · Traditional | 02/09/2017SE |
| K112759 | Apclo Pedicle Screw SystemsNKB · Special | 10/18/2011SE |
Questions and answers
When was Atlas Spine Expandable Cervical Standalone Interbody System cleared by the FDA?
Atlas Spine Expandable Cervical Standalone Interbody System (K192570) received a 510(k) decision of Substantially Equivalent on February 28, 2020, 163 days after the submission was received.
What is the product code of K192570?
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.