← Back to catalogue

OptiMesh Multiplanar Expandable Interbody Fusion System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
OptiMesh Multiplanar Expandable Interbody Fusion System FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
Guide Pin, Trocar/Round, 2.4mm Dia. X 508mm Long FDA UDI
Model / Reference
32-15-185 FDA UDI
Description
Guide Pin, Trocar/Round, 2.4mm Dia. X 508mm Long FDA UDI

Identifiers

Catalog Number
300-1010 FDA UDI
Primary DI / UDI-DI
M7403001010 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.4 Millimeter FDA UDI
Length — 508 Millimeter FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

OptiMesh Multiplanar Expandable Interbody Fusion System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI e19e9301-2d40-4d20-87ad-62b5f957e1ef 36 fields · synced May 30, 2026