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 depth gauge, reusable FDA UDI
Device Name: TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 2 FDA UDI
Model / Reference: P10-942-APD2 FDA UDI
Description: TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 2 FDA UDI

Identifiers

Catalog Number: P10-942-APD2 FDA UDI
Primary DI / UDI-DI: 00889795113528 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical depth gauge, 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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Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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 86cb59c8-d226-409b-a7f9-e4c69bef38ef 34 fields · synced May 31, 2026