APEX Knee System

FDA UDI

Class I (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Knee System FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: Paragon Broach w chip breakers, size 1 FDA UDI
Model / Reference: XG-80013-21-01 FDA UDI
Description: Paragon Broach w chip breakers, size 1 FDA UDI

Identifiers

Catalog Number: XG-80013-21-01 FDA UDI
Primary DI / UDI-DI: 00841690183938 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

APEX Knee System by OMNIlife science, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic broach.

EcoFit® broach for short stem 133° — implantcast GmbH · Class I
PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Equinoxe — Exactech, Inc. · Class II
Anthology — Smith & Nephew, Inc. · Class I
Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OMNIlife science, Inc.

Sources (1)

FDA UDI 976a8ffd-ebe7-4afb-b302-5e818ff9779f 35 fields · synced Jun 9, 2026