Phantom Hindfoot TTC/TC Nail System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Phantom Hindfoot TTC/TC Nail System FDA UDI
Generic Name: Bone-nailing compression screw FDA UDI
Device Name: Phantom Hindfoot Nail, Internal Compression Screw FDA UDI
Model / Reference: P31-101-0000-03 FDA UDI
Description: Phantom Hindfoot Nail, Internal Compression Screw FDA UDI

Identifiers

Catalog Number: P31-101-0000-03 FDA UDI
Primary DI / UDI-DI: 00889795098238 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone-nailing compression screw 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

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: Bone-nailing compression screw

Phantom Hindfoot TTC/TC Nail System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-nailing compression screw.

ELOS INSTRUMENTS — INTRAUMA SPA · Class II
3.0mm Compression Tool — INTERVENTIONAL SPINE, INC · Class I
REDUCTION BOLT, TIBIAL INSERTION GUIDE, SUPRAPATELLAR — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
ELOS INSTRUMENTS — INTRAUMA SPA · Class II
Compressor — Orthopedic Designs North America, Inc. · Class I
Compression Tool with Tray — INTERVENTIONAL SPINE, INC · Class I
Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I

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 5653d762-6618-469a-9b97-5126f21ff241 34 fields · synced May 30, 2026