Cavetto [MAX] Cervical Cage System
FDA 510(k) K201769 · Neurostructures, Inc.
510(k) numberK201769
Submission
- Device name
- Cavetto [MAX] Cervical Cage System
- Applicant
- Neurostructures, Inc.
Irvine, CA, US - Received
- June 29, 2020
- Decision date
- September 3, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, 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.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K202190 | Oculus-SA Lumbar Cage SystemOVD · Traditional | 10/02/2020SE |
| K200115 | Cavetto-SA Cervical Cage SystemOVE · Special | 09/24/2020SE |
| 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 [MAX] Cervical Cage System cleared by the FDA?
Cavetto [MAX] Cervical Cage System (K201769) received a 510(k) decision of Substantially Equivalent on September 3, 2020, 66 days after the submission was received.
What is the product code of K201769?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.