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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
Orthopaedic osteotome handle FDA UDI
Device Name
Shaper Body FDA UDI
Model / Reference
35-06-81 FDA UDI
Description
Shaper Body FDA UDI

Identifiers

Catalog Number
312-0050 FDA UDI
Primary DI / UDI-DI
M7403120050 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic osteotome handle 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic osteotome handle

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 osteotome handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 3892cbbe-6b71-4fa9-baf7-b2ce5d8ebedb 35 fields · synced May 31, 2026