CORENTEC CO., LTD

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
33
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1934-2024Class IILOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: TiMarch 29, 2024
Z-1935-2024Class IILOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product DescriptionMarch 29, 2024
Z-1454-2017Class IIBencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343February 27, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K250889EXULT Knee Replacement SystemApril 17, 2025
K242401EXULT Knee Replacement SystemSeptember 12, 2024
K242046EXULT Knee Replacement SystemAugust 1, 2024
K223828BENCOX Delta Option HeadsMarch 16, 2023
K223223BENCOX Mirabo Z Cup CortiniumFebruary 27, 2023
K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationAugust 26, 2022
K210614BENCOX Mirabo Z Cup CortiniumMay 24, 2022
K220468BENCOX Mirabo Cup SystemMay 18, 2022
K212034LOSPA TKR SystemDecember 9, 2021
K211866Bencox THR SystemJuly 14, 2021
K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightJuly 30, 2020
K200395LOSPA II Knee System (EXULT Knee Replacement System)May 7, 2020
K200267LOSPA® IS™ Spinal Fixation SystemMarch 6, 2020
K192507LOSPA II Knee SystemDecember 11, 2019
K182221Bencox Mirabo Cup Multi HoleApril 1, 2019
K172806Bencox Mirabo Cup SystemOctober 17, 2017
K170243LOSPA IS TLIF & DLIF CagesMarch 31, 2017
K161641LOSPA IS ACP SystemJanuary 5, 2017
K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemDecember 5, 2016
K160157LOSPA Modular Knee SystemDecember 1, 2016