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OptiMesh Multiplanar Expandable Interbody Fusion System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251302

by Spineology Inc.

Identifiers

510(k) Number
K251302 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. It is a porous mesh container knitted from polyester yarn made of polyethylene terephthalate (PET) thread and is designed to contain bone graft as an adjunct to fusion in instrumented lumbar fusion procedures.

The device is supplied as a single implant intended for use in lumbar fusion procedures, accommodating multiple approaches including open, MIS TLIF, ultra-MIS (OptiLIF), and endoscopic fusion (OptiLIF Endo). It is classified as a Class II medical device under FDA regulation, with product code OQB and regulation number 888.3085, and has received traditional 510(k) clearance (K251302) as substantially equivalent to a predicate device.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spineology Inc.
FDA Applicant
Spineology, Inc.

Sources (1)

  • FDA 510(k) K251302 24 fields · synced Sep 26, 2026