Monster Screw System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Monster Screw System FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: K-wire, Single Ended Trocar Tip, SMOOTH, 2.3 x 230mm FDA UDI
Model / Reference: P99-192-2323 FDA UDI
Description: K-wire, Single Ended Trocar Tip, SMOOTH, 2.3 x 230mm FDA UDI

Identifiers

Catalog Number: P99-192-2323 FDA UDI
Primary DI / UDI-DI: 00889795152992 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

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

Yes

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: Orthopaedic bone pin, non-bioabsorbable

Monster Screw System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, 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 I	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 9cafdc16-1a14-4687-ad30-812f5a730f71 34 fields · synced May 31, 2026