ALPHALOK Plating System

FDA UDI

Class I (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name: ALPHALOK Plating System FDA UDI
Generic Name: Surgical countersink, single-use FDA UDI
Device Name: MET FX 2.0/2.5mm Countersink FDA UDI
Model / Reference: TCS20-25 FDA UDI
Description: MET FX 2.0/2.5mm Countersink FDA UDI

Identifiers

Catalog Number: TCS20-25 FDA UDI
Primary DI / UDI-DI: 00841731130976 FDA UDI
FDA Product Code: HWW FDA UDI
GMDN Term: Surgical countersink, 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: Surgical countersink, 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 Surgical countersink, single-use.

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CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
FuzeFix Mini — FUSION ORTHOPEDICS, 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 I	Pending data

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Manufacturer

Manufacturer: Vilex, Inc.

Sources (1)

FDA UDI 5429c5a2-41c4-490a-8f8a-447264a48fca 34 fields · synced May 31, 2026