Aprevo Anterior Lumbar Interbody Fusion Device with Interfixation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241477 FDA 510(k)
- FDA Product Code
- OVD 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 anterior lumbar interbody fusion device with interfixation is a spinal implant intended for interbody fusion in skeletally mature patients. It is designed to be used as an adjunct to fusion at one or more levels of the lumbar spine.
The device is supplied sterile and is intended for single-use. It is indicated for use in patients with degenerative disc disease, disc herniation, spondylolisthesis, spinal deformity, spinal stenosis, or failed previous fusion. Authorizations include FDA 510(k) clearance under product code OVD.
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: aprevo® anterior lumbar interbody fusion device with interfixation ..., PDF aprevo® anterior and lateral Intervertebral Body - carlsmed.com, PDF aprevo® anterior and lateral lumbar interbody system
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241477 | Class II | Active |
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Manufacturer
- Manufacturer
- Carlsmed, Inc.
Sources (1)
- FDA 510(k) K241477 24 fields · synced Sep 25, 2026