APEX 3D Total Ankle Replacement System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: APEX 3D Total Ankle Replacement System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: 3.5MM Hex Screw Driver, 225mm Length FDA UDI
Model / Reference: P99-150-HX35 FDA UDI
Description: 3.5MM Hex Screw Driver, 225mm Length FDA UDI

Identifiers

Catalog Number: P99-150-HX35 FDA UDI
Primary DI / UDI-DI: 00889795064103 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Surgical screwdriver, reusable 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 08e0c313-95dd-40bc-8ab4-e09d50bde784 34 fields · synced Jun 8, 2026