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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
Surgical retractor/retraction system blade, reusable FDA UDI
Device Name
Expandable Rake (Non-Toothed) FDA UDI
Model / Reference
35-06-38 FDA UDI
Description
Expandable Rake (Non-Toothed) FDA UDI

Identifiers

Catalog Number
315-0028 FDA UDI
Primary DI / UDI-DI
M7403150028 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical retractor/retraction system blade, reusable 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

Category: Surgical retractor/retraction system blade, reusable

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 Surgical retractor/retraction system blade, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 29ea4c30-2a94-4ada-8090-008b046f83a4 35 fields · synced Jun 8, 2026