VerteGlide Spinal Growth Guidance System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: VerteGlide Spinal Growth Guidance System FDA UDI
Generic Name: Orthopaedic guidewire, reusable FDA UDI
Device Name: GUIDE WIRE FDA UDI
Model / Reference: 01-1720-0300 FDA UDI
Description: GUIDE WIRE FDA UDI

Identifiers

Catalog Number: 01-1720-0300 FDA UDI
Primary DI / UDI-DI: 00840194480154 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic guidewire, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic guidewire, reusable

VerteGlide Spinal Growth Guidance System by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, reusable.

Orthopaedic Spreader — Synthes GmbH · Class IIa
LCP — Synthes GmbH · Class IIa
Guide Wire — I.T.S. GmbH · Class I
Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
VERTECEM — Synthes GmbH · Class IIa
Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
ZERO-P — Synthes GmbH · Class IIa
Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI 8b6d861e-aa35-4998-a055-9de559c71138 35 fields · synced May 30, 2026