FDA.reportPublic FDA data

510(k) K242401

Device
EXULT Knee Replacement System
Applicant
Corentec Co., Ltd.
510(k) number
K242401
Product code
JWH
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-12
Date received
2024-08-13
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Seo Sanghee
Address
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-Si Chungchongnam-Do KR 31056 31056

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.2025-03-24