FDA 510(k) Applications Submitted by Corentec Co., Ltd

FDA 510(k) Number Submission Date Device Name Applicant
K160157 01/22/2016 LOSPA Modular Knee System CORENTEC CO., LTD
K150007 01/02/2015 Modified Bencox Hip System Corentec Co., Ltd
K151408 05/26/2015 LOSPA IS Spinal System CORENTEC CO., LTD
K152084 07/27/2015 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug CORENTEC CO., LTD
K162127 08/01/2016 Bencox M Stem Lateralized & Bencox Mirabo Cup System CORENTEC CO., LTD
K172806 09/18/2017 Bencox Mirabo Cup System Corentec Co., Ltd
K170243 01/26/2017 LOSPA IS TLIF & DLIF Cages CORENTEC CO., LTD
K130673 03/12/2013 LOSPA TOTAL KNEE REPLACEMENT SYSTEM CORENTEC CO., LTD
K120924 03/27/2012 BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG CORENTEC CO., LTD
K121037 04/05/2012 LOSPA TIBIAL BASE PLATE CORENTEC CO., LTD
K121665 06/06/2012 BENCOX FORET & BENCOX DELTA CORENTEC CO., LTD
K161641 06/14/2016 LOSPA IS ACP System CORENTEC CO., LTD
K112019 07/14/2011 BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP CORENTEC CO., LTD
K122099 07/16/2012 BENCOX II STEM, BENCOX METAL HEAD CORENTEC CO., LTD
K182221 08/16/2018 Bencox Mirabo Cup Multi Hole Corentec Co., Ltd
K132644 08/26/2013 LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU CORENTEC CO., LTD
K192507 09/12/2019 LOSPA II Knee System Corentec Co., Ltd
K110404 02/14/2011 EAUM TOTAL KNEE SYSTEM CORENTEC CO., LTD
K103431 11/23/2010 COREN TOTAL HIP SYSTEM CORENTEC CO., LTD
K092076 07/09/2009 AEGIS & AEGIS II SPINAL SYSTEM CORENTEC CO., LTD
K200395 02/18/2020 LOSPA II Knee System (EXULT Knee Replacement System) Corentec Co., Ltd
K201851 07/06/2020 EXULT Femoral component trial - Left, EXULT Femoral component trial - Right Corentec Co., Ltd


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