Cavetto-SA Cervical Cage System
FDA 510(k) K200115 · Neurostructures, Inc.
510(k) numberK200115
Submission
- Device name
- Cavetto-SA Cervical Cage System
- Applicant
- Neurostructures, Inc.
Irvine, CA, US - Received
- January 21, 2020
- Decision date
- September 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K202190 | Oculus-SA Lumbar Cage SystemOVD · Traditional | 10/02/2020SE |
| K201769 | Cavetto [MAX] Cervical Cage SystemODP · Traditional | 09/03/2020SE |
| K200927 | Transept Cervical Plate SystemKWQ · Traditional | 07/24/2020SE |
| K192248 | Cortina [MAX] Lumbar Cage SystemMAX · Special | 11/25/2019SE |
| K182195 | Arco-SA Lumbar Cage SystemOVD · Special | 11/09/2018SE |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage SystemODP · Special | 11/08/2018SE |
| K173082 | Arco-SA Lumbar Cage SystemOVD · Traditional | 03/29/2018SE |
| K180431 | Cortina [MAX] Lumbar Cage SystemMAX · Traditional | 03/22/2018SE |
| K172320 | Neurostructures Cavetto® Cervical Cage SystemODP · Traditional | 02/26/2018SE |
| K173077 | Cavetto-SA Cervical Cage SystemOVE · Traditional | 02/23/2018SE |
Questions and answers
When was Cavetto-SA Cervical Cage System cleared by the FDA?
Cavetto-SA Cervical Cage System (K200115) received a 510(k) decision of Substantially Equivalent on September 24, 2020, 247 days after the submission was received.
What is the product code of K200115?
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.