Medical Device Manufacturer · US , West Cadwell , NJ

Corentec Co., Ltd. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 2010

Recent clearances: EXULT Knee Replacement System, EXULT Knee Replacement System, EXULT Knee Replacement System

33

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Corentec Co., Ltd. Orthopedic ✕

33 devices

1-12 of 33

Cleared Apr 17, 2025

EXULT Knee Replacement System

Orthopedic · 23d

Cleared Sep 12, 2024

EXULT Knee Replacement System

Orthopedic · 30d

Cleared Aug 01, 2024

EXULT Knee Replacement System

Orthopedic · 20d

Cleared Mar 16, 2023

BENCOX Delta Option Heads

Orthopedic · 85d

Cleared Feb 27, 2023

BENCOX Mirabo Z Cup Cortinium

Orthopedic · 133d

Cleared Aug 26, 2022

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

Orthopedic · 28d

Cleared May 24, 2022

BENCOX Mirabo Z Cup Cortinium

Orthopedic · 449d

Cleared May 18, 2022

BENCOX Mirabo Cup System

Orthopedic · 90d

Cleared Dec 09, 2021

LOSPA TKR System

Orthopedic · 163d

Cleared Jul 14, 2021

Bencox THR System

Orthopedic · 28d

Cleared Jul 30, 2020

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right

Orthopedic · 24d

Cleared May 07, 2020

LOSPA II Knee System (EXULT Knee Replacement System)

Orthopedic · 79d