Phantom® Fibula Nail System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Phantom® Fibula Nail System FDA UDI
Generic Name: Surgical countersink, single-use FDA UDI
Device Name: Screw Countersink, AO Quick Connect FDA UDI
Model / Reference: P36-911-2735 FDA UDI
Description: Screw Countersink, AO Quick Connect FDA UDI

Identifiers

Catalog Number: P36-911-2735 FDA UDI
Primary DI / UDI-DI: 00889795137098 FDA UDI
FDA Product Code: HWW FDA UDI
GMDN Term: Surgical countersink, 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical countersink, single-use

Phantom® Fibula Nail System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical countersink, single-use.

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CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
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FuzeFix Mini — FUSION ORTHOPEDICS, LLC · 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 4e7d3c68-e69d-4489-a87f-f5945eba3804 34 fields · synced Jun 1, 2026