Vilex Implant Accessory

FDA UDI

Class II (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name: Vilex Implant Accessory FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: Washer, 4.0mm Ti - T40 Screw FDA UDI
Model / Reference: 635T-40T FDA UDI
Description: Washer, 4.0mm Ti - T40 Screw FDA UDI

Identifiers

Primary DI / UDI-DI: 00841731114884 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

Vilex Implant Accessory 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

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Manufacturer

Manufacturer: Vilex, Inc.

Sources (1)

FDA UDI 4f6b07a2-9f5a-48cd-8de8-9b0b04e10509 33 fields · synced Jun 8, 2026