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-resection orthopaedic reamer, single-use FDA UDI
Device Name: Stepped Reamer FDA UDI
Model / Reference: P99-110-0813 FDA UDI
Description: Stepped Reamer FDA UDI

Identifiers

Catalog Number: P99-110-0813 FDA UDI
Primary DI / UDI-DI: 00889795056832 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, single-use 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-resection orthopaedic reamer, single-use

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

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Also classified as Bone-resection orthopaedic reamer, single-use.

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Disposable — Biomet Orthopedics, Inc. · Class I
PANTA® — Newdeal Sas · Class I
ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
Arthrex® — Arthrex, Inc. · Class I
Tools - UFC — Trimed, INC. · 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 952d3c14-2c02-4ab9-93ff-de873b3749ba 34 fields · synced May 30, 2026