APEX 3D Total Ankle Replacement System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: APEX 3D Total Ankle Replacement System FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Total Ankle, Instrument, Poly Trial Insert, Size 5, 15MM, 4.00MM ANT/POST Offset, PPSU FDA UDI
Model / Reference: P10-931-I515 FDA UDI
Description: Total Ankle, Instrument, Poly Trial Insert, Size 5, 15MM, 4.00MM ANT/POST Offset, PPSU FDA UDI

Identifiers

Catalog Number: P10-931-I515 FDA UDI
Primary DI / UDI-DI: 00889795121639 FDA UDI
FDA Product Code: HSN FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 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

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 implant template, reusable

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

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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 II	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI ac123af3-4ab7-440e-9205-6cbf250898af 34 fields · synced May 30, 2026