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: Bone-coring punch, reusable FDA UDI
Device Name: Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 1 FDA UDI
Model / Reference: P10-851-TPR1 FDA UDI
Description: Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 1 FDA UDI

Identifiers

Catalog Number: P10-851-TPR1 FDA UDI
Primary DI / UDI-DI: 00889795114006 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Bone-coring punch, 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bone-coring punch, 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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Also classified as Bone-coring punch, reusable.

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GENESIS II — Smith & Nephew, Inc. · 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 4f87f4ef-3037-4db1-9141-17b6334ee390 34 fields · synced Jun 8, 2026