LumiVy Lumbar IBF System
FDA 510(k)Class II (US FDA 510(k))
by Vy Spine Llc
Identifiers
- 510(k) Number
- K233807 FDA 510(k)
- FDA Product Code
- MAX 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 LumiVy Lumbar IBF System is a device for intervertebral body fusion of the spine in skeletally mature patients. It is designed for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease with up to Grade 1 spondylolisthesis.
The device systems are supplied for use in spine surgery and are designed to optimize surgical outcomes. The LumiVy Lumbar IBF System is authorized under FDA 510(k) clearance with K number K233807 and product code MAX.
Frequently asked questions
What is the LumiVy Lumbar IBF System used for?
The LumiVy Lumbar IBF System is designed for intervertebral body fusion of the spine in skeletally mature patients at one or two contiguous levels in the lumbar spine from L2 to S1, specifically for treating degenerative disc disease with up to Grade 1 spondylolisthesis.
How is the LumiVy Lumbar IBF System supplied?
The LumiVy Lumbar IBF System is supplied as a complete device system for use in spine surgery, designed to optimize surgical outcomes. The specific components and packaging details would be provided by the manufacturer, VY SPINE LLC.
What is the regulatory status of the LumiVy Lumbar IBF System?
The LumiVy Lumbar IBF System is authorized under FDA 510(k) clearance with K number K233807 and product code MAX. This means it has been determined to be substantially equivalent to existing predicate devices for its intended use.
Can the LumiVy Lumbar IBF System be reused?
The device data does not specify whether the LumiVy Lumbar IBF System is single-use or reusable. This information would typically be provided in the device's instructions for use, which should be consulted for proper handling and sterilization protocols.
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: LumiVy™ Lumbar IBF - Vy Spine, LumiVy™-AS Lumbar IBF - Vy Spine, LumiVy™ Lumbar IBF System (K223412) — FDA 510(k) | Innolitics, LumiVy Lumbar IBF System (K212930) — FDA 510 (k) | Innolitics, LumiVy Lumbar IBF System (K233807) | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233807 | Class II | Active |
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Manufacturer
- Manufacturer
- Vy Spine Llc
- FDA Applicant
- Vy Spine, LLC
Sources (1)
- FDA 510(k) K233807 24 fields · synced Sep 22, 2026