OptiMesh Multiplanar Expandable Interbody Fusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231781 FDA 510(k)
- FDA Product Code
- OQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3085 FDA 510(k)
- Regulation Number
- 888.3085 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OptiMesh Multiplanar Expandable Interbody Fusion System is an Intervertebral Body Graft Containment Device designed to contain bone graft material during spinal fusion procedures. It is a porous, expandable mesh implant constructed from polyethylene terephthalate (PET) yarn, engineered to accommodate multiplanar lumbar fusion approaches, including open, minimally invasive (MIS), and endoscopic techniques.
This device is supplied sterile and intended for single-use in instrumented lumbar fusion surgeries for degenerative disc disease. It is classified as a Class II medical device under FDA regulations (21 CFR 888.3085) and holds a Special 510(k) clearance (K231781) from the Orthopedic Devices Panel. The expandable design allows for customizable placement and stabilization, with sizes and configurations tailored to specific surgical approaches.
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: OptiMesh - Spineology, PDF OptiMesh® Multiplanar Expandable Interbody Fusion System, OptiMesh Multiplanar Expandable Interbody Fusion System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231781 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K231781 24 fields · synced Sep 19, 2026