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ALPHALOK Plating System

FDA UDI

Class I (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name
ALPHALOK Plating System FDA UDI
Generic Name
Orthopaedic bone wire FDA UDI
Device Name
MET FX Plate Wire Medium, 1.2mm FDA UDI
Model / Reference
K60-12M FDA UDI
Description
MET FX Plate Wire Medium, 1.2mm FDA UDI

Identifiers

Catalog Number
K60-12M FDA UDI
Primary DI / UDI-DI
00841731130969 FDA UDI
FDA Product Code
HXI FDA UDI
GMDN Term
Orthopaedic bone wire 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

Yes

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

No

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

Category: Orthopaedic bone wire

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

Similar devices

Also classified as Orthopaedic bone wire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vilex, Inc.

Sources (1)

  • FDA UDI 4784774f-8fba-4860-8e4e-910783911709 34 fields · synced May 31, 2026