ALPHALOK Plating System

FDA UDI

Class II (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name: ALPHALOK Plating System FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: RECON Tarantula Plate Washer, 15mm FDA UDI
Model / Reference: TL-12-SW FDA UDI
Description: RECON Tarantula Plate Washer, 15mm FDA UDI

Identifiers

Catalog Number: TL-15-SW FDA UDI
Primary DI / UDI-DI: 00841731128782 FDA UDI
FDA Product Code: HTN FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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

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: Implantable bone washer

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

Similar devices

Also classified as Implantable bone washer.

ISOLA — Depuy Spine, Inc. · Class II
Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
Monster Screw System — Paragon 28 · Class II
Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · Class II
FacetLink System — WALDEMAR LINK GmbH & Co. KG · U

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vilex, Inc.

Sources (1)

FDA UDI a3f8db39-5ef4-4c4f-b1c9-48bad5741161 34 fields · synced May 30, 2026