aprevo cervical interbody system
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252894 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 aprevo cervical interbody system is a device designed for spinal fusion procedures in the cervical region. It is intended to facilitate interbody fusion by providing structural support and promoting bone growth between adjacent vertebrae.
The device is supplied as a sterile, single-use implant and is used in hospital surgical settings. It has received FDA 510(k) clearance under product code ODP and is indicated for use in cervical interbody fusion applications as specified in its authorization.
Frequently asked questions
What is the aprevo cervical interbody system used for?
The aprevo cervical interbody system is used in spinal fusion procedures in the cervical region to facilitate interbody fusion by providing structural support and promoting bone growth between adjacent vertebrae, as indicated in its FDA 510(k) clearance.
How is the aprevo cervical interbody system supplied and is it reusable?
The device is supplied as a sterile, single-use implant intended for one-time use in hospital surgical settings, ensuring sterility and eliminating the need for reprocessing or reuse.
What regulatory pathway was used for the aprevo cervical interbody system?
The aprevo cervical interbody system received FDA 510(k) clearance under product code ODP, with a traditional clearance type and a substantially equivalent decision, as documented in its authorization details.
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: Carlsmed, Carlsmed's aprevo® Powers First Personalized Cervical Spine Surgery, Carlsmed Announces FDA Clearance for aprevo® Cervical Breakthrough ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252894 | Class II | Active |
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Manufacturer
- Manufacturer
- Carlsmed, Inc.
Sources (1)
- FDA 510(k) K252894 24 fields · synced Sep 24, 2026