Corentec Co., Ltd. FDA Approvals

0 new drug approvals and 10 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
EXULT Knee Replacement System510(k)Apr 17, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 17, 2025
EXULT Knee Replacement System510(k)Sep 12, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 12, 2024
EXULT Knee Replacement System510(k)Aug 1, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 1, 2024
BENCOX Delta Option Heads510(k)Mar 16, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 16, 2023
BENCOX Mirabo Z Cup Cortinium510(k)Feb 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 27, 2023
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation510(k)Aug 26, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 26, 2022
BENCOX Mirabo Z Cup Cortinium510(k)May 24, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 24, 2022
BENCOX Mirabo Cup System510(k)May 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 18, 2022
LOSPA TKR System510(k)Dec 9, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 9, 2021
Bencox THR System510(k)Jul 14, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 14, 2021