ALPHALOK Plating System

FDA UDI

Class I (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name: ALPHALOK Plating System FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: Wire, Plate Holding, SP-Shaped Ø1.8mm Smooth FDA UDI
Model / Reference: K60-18S FDA UDI
Description: Wire, Plate Holding, SP-Shaped Ø1.8mm Smooth FDA UDI

Identifiers

Catalog Number: K60-18S FDA UDI
Primary DI / UDI-DI: 00841731147554 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic guidewire, 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

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic guidewire, single-use

ALPHALOK Plating System by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic guidewire, single-use.

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Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · 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: Vilex, Inc.

Sources (1)

FDA UDI a2b367d9-cfd8-4e5e-9162-7a3aa4dc62b7 34 fields · synced May 30, 2026