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: Surgical instrument handle, torque-limiting FDA UDI
Device Name: U Handle FDA UDI
Model / Reference: P99-150-2007 FDA UDI
Description: U Handle FDA UDI

Identifiers

Catalog Number: P99-150-2007 FDA UDI
Primary DI / UDI-DI: 00889795130914 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical instrument handle, torque-limiting 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical instrument handle, torque-limiting

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 Surgical instrument handle, torque-limiting.

TLX — Nuvasive, Inc. · Class I
Tecomet — Tecomet,Inc · Class I
Tecomet — Tecomet,Inc · Class I
PERLA ® — Spineart · Class II
Tecomet — Tecomet,Inc · Class I
ReLine — Nuvasive, Inc. · Class I
InCore MPJ — Medartis Inc. · Class I
KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI d445787f-2d57-48a3-802d-e7753f557273 34 fields · synced Jun 6, 2026