Opticage Interbody Fusion Device, Model 9080-00
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132479 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 Opticage Interbody Fusion Device, Model 9080-00, is a metallic spinal interbody fusion cage designed for cervical or lumbosacral spine applications. This expandable implant is inserted into the intervertebral body space to facilitate spinal fusion, providing structural support and promoting bony union between adjacent vertebrae.
This device is supplied sterile and intended for single-use in open surgical procedures. It is classified under the FDA’s Special Controls for Class II devices and holds a 510(k) clearance (K132479) for substantial equivalence in the orthopedic category. Storage and handling must comply with sterile surgical instrument protocols, and its use is governed by the manufacturer’s instructions for proper positioning and fixation.
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: Opticage Interbody Fusion Device, Model 9080-00, Opticage Interbody Fusion Device, Model 9080-00, AccessGUDID - 9080-00, fda.innolitics.com, Class 2 Device Recall G3 Opticage Expandable Interbody Fusion Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132479 | Class II | Active |
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Manufacturer
- Manufacturer
- Interventional Spine, Inc
- FDA Applicant
- Interventional Spine, Inc.
Sources (1)
- FDA 510(k) K132479 24 fields · synced Sep 19, 2026