Vertefix

FDA UDI

Class II (US FDA UDI)

by Elite Surgical Supplies (pty) Ltd

Identity

Trade Name: Vertefix FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Multi Axial Extension Pedicle Screw 6.5x40mm FDA UDI
Model / Reference: MAE6540T FDA UDI
Description: Multi Axial Extension Pedicle Screw 6.5x40mm FDA UDI

Identifiers

Catalog Number: MAE6540T FDA UDI
Primary DI / UDI-DI: 06009696221434 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Spinal bone screw, non-bioabsorbable Spinal bone set screw Spinal bone screw head/rod adaptor

Vertefix by Elite Surgical Supplies (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw head/rod adaptor.

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Reform Pedicle Screw System — Precision Spine, Inc. · Class II
Reform Ti CT Modular MIS Pedicle Screw System — Precision Spine, Inc. · Class II
DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
Inertia® CONNEXX™ Modular Pedicle Screw System — NEXXT SPINE LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elite Surgical Supplies (pty) Ltd

Sources (1)

FDA UDI 38d4d7b0-63c4-4e73-a428-5229cbdb8acc 34 fields · synced May 30, 2026