Cavetto [MAX] Cervical Cage System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201769 FDA 510(k)
- FDA Product Code
- ODP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cavetto [MAX] Cervical Cage System is an intervertebral fusion device made of titanium (ASTM F136) designed to provide structural support during cervical fusion. It is intended for use with supplemental fixation and is implanted via an open anterior approach.
The device is supplied as a single-use implant and is intended for use with autogenous or allogenic bone graft. It is an FDA 510(k) cleared device classified as Class II with Special Controls under product code ODP.
Frequently asked questions
What is the Cavetto MAX Cervical Cage System made of?
The device is constructed from titanium (ASTM F136) to provide structural support during cervical fusion procedures.
How is the Cavetto MAX Cervical Cage System supplied?
It is supplied as a single-use implant intended for use with autogenous or allogenic bone graft.
What is the regulatory status of the Cavetto MAX Cervical Cage System?
It is an FDA 510(k) cleared device classified as Class II with Special Controls under product code ODP.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neurostructures Cavetto® [MAX] Cervical Cage System (K181590) — FDA 510 ..., K181590 - Neurostructures Cavetto® [MAX] Cervical Cage System, Cavetto [MAX] Cervical Cage System (K201769) - FDA 510(k), Cavetto [MAX] Cervical Cage System (K201769) - FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201769 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurostructures, Inc
- FDA Applicant
- Neurostructures, Inc.
Sources (1)
- FDA 510(k) K201769 24 fields · synced Sep 25, 2026