EXULT Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name: EXULT Knee Replacement System FDA UDI
Generic Name: Sleeve femoral/tibial extension, uncoated FDA UDI
Device Name: Primary Stem Extension FDA UDI
Model / Reference: KC.COT.E001 FDA UDI
Description: Primary Stem Extension FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017297217 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Sleeve femoral/tibial extension, uncoated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Sleeve femoral/tibial extension, uncoated

EXULT Knee Replacement System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sleeve femoral/tibial extension, uncoated.

Pantheon System — ADLER ORTHO SPA · Class II
REDAPT — Smith & Nephew, Inc. · Class II
Tibial Stem Extension Reamer — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Pantheon System — ADLER ORTHO SPA · Class II
Pantheon System — ADLER ORTHO SPA · Class II
MUTARS® extension piece — implantcast GmbH · Class II
MUTARS® connecting part — implantcast GmbH · Class II
REDAPT — 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 II	Pending data

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Manufacturer

Manufacturer: Corentec Co., Ltd

Sources (1)

FDA UDI 9eee3fb2-c7e1-4417-adc2-c7d096b26a04 34 fields · synced May 31, 2026