Monster Screw System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: Monster Screw System FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: Monster Screw Slotted Bowl Washer, 7.0mm FDA UDI
Model / Reference: P20-070-WFS0 FDA UDI
Description: Monster Screw Slotted Bowl Washer, 7.0mm FDA UDI

Identifiers

Catalog Number: P20-070-WFS0 FDA UDI
Primary DI / UDI-DI: 00889795035332 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

MRI Safety

MR Unsafe FDA UDI

Category: Implantable bone washer

Monster Screw System by Paragon 28 — 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
ALPHALOK Plating System — Vilex, Inc. · 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
Washers — Trimed, INC. · 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 II	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 1d308a83-75d2-44fc-a209-b432d4b29080 34 fields · synced May 30, 2026