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: Uncoated hip femur prosthesis, modular FDA UDI
Device Name: Femur Protector FDA UDI
Model / Reference: KA.CF0.N001 FDA UDI
Description: Femur Protector FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017297842 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Uncoated hip femur prosthesis, modular 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: Uncoated hip femur prosthesis, modular

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 Uncoated hip femur prosthesis, modular.

Accolade — Howmedica Osteonics Corp. · Class II
SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
Corin Taper-Fit Total Hip System — CORIN LTD · Class II
TaperFit Cemented Hip System — CORIN LTD · Class II
Omnifit — Howmedica Osteonics Corp. · Class II
SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · 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

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

Manufacturer

Manufacturer: Corentec Co., Ltd

Sources (1)

FDA UDI fac30d50-e26c-457e-8ab6-b65d1cc90e3e 34 fields · synced May 30, 2026