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 fixation implant alignment tool FDA UDI
Device Name: ADJUSTABLE STYLUS FDA UDI
Model / Reference: KS-71010 FDA UDI
Description: ADJUSTABLE STYLUS FDA UDI

Identifiers

Catalog Number: KS-71010 FDA UDI
Primary DI / UDI-DI: 00841690190011 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool 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

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 fixation implant alignment tool

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 fixation implant alignment tool.

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“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) — Paonan Biotech Co., Ltd. · Class I
U1™ Hip — UNITED ORTHOPEDIC CORP. · Class I
U2™ Knee — UNITED ORTHOPEDIC CORP. · Class I
U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
Easyspine — Ldr Spine USA · 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: OMNIlife science, Inc.

Sources (1)

FDA UDI e5645fcd-28e4-4ccb-831f-ae8c2c32a689 35 fields · synced Jun 9, 2026