Corentec Co L T D

FDA Filings

This page includes the latest FDA filings for Corentec Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

104540

DUNS 688739895

FDA Registration(s)

• Registration Number: 3009106092
• FEI Number: 3009106092
• Name: Michael Van Der Woude
• Owner & Operator: Corentec Co., Ltd.
• Contact Address: 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu,; Cheonan Si, KR-44 Chungcheongnamdo 31056 KR
• US Agent:
  • Michael Van Der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009276448
• FEI Number: 3009276448
• Name: Corentec America Inc
• Owner & Operator: Corentec Co., Ltd.
• Contact Address: 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu,; Cheonan Si, KR-44 Chungcheongnamdo 31056 KR
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 60 Washington St Ste 202 ; Morristown, NJ 07960 US

FDA Filings

Device Company	Device	Date
GUDID 08800068960368 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068960047 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068960030 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068960023 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068960016 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068960009 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068959997 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068959980 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068959973 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068959607 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068959591 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800017299006 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-08
GUDID 08800068977588 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-05
GUDID 08800068959843 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-05
GUDID 08800068958853 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-05
GUDID 08800068958846 Corentec Co., Ltd	Lospa Surgical Instruments	2024-11-05
GUDID 08800017205311 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-29
GUDID 08800017205281 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-29
GUDID 08800017205274 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-29
GUDID 08806373898648 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373894619 Corentec Co., Ltd	LOSPA Knee System	2024-10-28
GUDID 08806373892547 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373892530 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373890116 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373890109 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373890093 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373890031 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889776 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889639 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889578 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889554 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889530 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889516 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889509 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889493 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889325 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373889318 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205878 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205861 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205854 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205847 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205830 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205823 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08800017205816 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-28
GUDID 08806373890123 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-24
GUDID 08806373889660 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-24
GUDID 08806373889271 Corentec Co., Ltd	Lospa Surgical Instruments	2024-10-24
GUDID 08800068981950 Corentec Co., Ltd	EXULT Surgical Instrument	2024-10-24
GUDID 08800068981943 Corentec Co., Ltd	EXULT Surgical Instrument	2024-10-24
GUDID 08809945893294 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891276 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891269 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891252 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891245 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891238 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891221 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891214 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891207 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891191 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891184 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891177 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891160 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891153 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891146 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891139 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891122 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891115 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891108 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891092 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891085 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891078 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891061 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891054 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891047 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891030 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891023 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891016 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945891009 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890996 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890989 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890972 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890965 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890958 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890941 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890934 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890927 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890910 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890903 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890897 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890880 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890873 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890866 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890859 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890842 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890835 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890828 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890811 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890804 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890798 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
GUDID 08809945890781 Corentec Co., Ltd	EXULT Knee Replacement System	2024-10-22
PMN K222278 Corentec Co., Ltd.	LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation	2022-08-26
PMN K210614 Corentec Co.,Ltd.	BENCOX Mirabo Z Cup Cortinium	2022-05-24
PMN K220468 Corentec Co.,Ltd.	BENCOX Mirabo Cup System	2022-05-18
PMN K212034 Corentec Co., Ltd.	LOSPA TKR System	2021-12-09
PMN K211866 Corentec Co., Ltd.	Bencox THR System	2021-07-14
PMN K201851 Corentec Co., Ltd	EXULT Femoral Component Trial - Left, EXULT Femoral Component Trial - Right	2020-07-30
PMN K200395 Corentec Co., Ltd	LOSPA II Knee System (EXULT Knee Replacement System)	2020-05-07
PMN K200267 | NKB Michael Van Der Woude [Corentec Co., Ltd.]	Rhino Percutaneous Pedicle Screw	2020-03-09
PMN K200267 | NKB Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS Thoracolumbar Pedicle Screw	2020-03-09
PMN K200267 | NKB Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS Spinal Fixation System	2020-03-09
PMN K200267 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	Rhino Percutaneous Pedicle Screw	2020-03-09
PMN K200267 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS Thoracolumbar Pedicle Screw	2020-03-09
PMN K200267 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS Spinal Fixation System	2020-03-09
PMN K200267 Corentec Co., Ltd.	LOSPA® IS™ Spinal Fixation System	2020-03-06
PMN K192507 | JWH Michael Van Der Woude [Corentec Co., Ltd.]	EXULT Knee Replacement System	2020-01-06
PMN K192507 Corentec Co., Ltd	LOSPA II Knee System	2019-12-11
PMN K182221 Corentec Co., Ltd	Bencox Mirabo Cup Multi Hole	2019-04-01
PMN K182221 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	Bencox	2019-04-01
PMN K172806 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2017-11-15
PMN K172806 Corentec Co., Ltd	Bencox Mirabo Cup System	2017-10-17
PMN K170243 | MAX Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2017-04-02
PMN K170243 CORENTEC CO., LTD	LOSPA IS TLIF & DLIF Cages	2017-03-31
PMN K161641 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2017-01-31
PMN K161641 CORENTEC CO., LTD	LOSPA IS ACP System	2017-01-05
PMN K162127 CORENTEC CO., LTD	Bencox M Stem Lateralized & Bencox Mirabo Cup System	2016-12-05
PMN K162127 | LZO Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-12-05
PMN K162127 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-12-05
PMN K162127 | KWY Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-12-05
PMN K160157 | JWH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2016-12-05
PMN K160157 CORENTEC CO., LTD	LOSPA Modular Knee System	2016-12-01
PMN K152084 | LZO Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-05-01
PMN K152084 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-05-01
PMN K152084 | KWY Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-05-01
PMN K152084 | JDI Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2016-05-01
PMN K152084 CORENTEC CO., LTD	Bencox M Stem (Bencox Hip System) And Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug	2016-04-29
PMN K151408 | ODP Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2015-10-22
PMN K151408 | ODP Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS	2015-10-22
PMN K151408 | MAX Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2015-10-22
PMN K151408 | MAX Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS	2015-10-22
PMN K150007 | LZO Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2015-10-22
PMN K150007 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2015-10-22
PMN K150007 | KWY Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2015-10-22
PMN K151408 CORENTEC CO., LTD	LOSPA IS Spinal System	2015-10-02
PMN K150007 Corentec Co., Ltd	Modified Bencox Hip System	2015-05-04
HXP Michael Van Der Woude [Corentec Co., Ltd.]	Lospa & Bencox	2014-04-17
HWB Michael Van Der Woude [Corentec Co., Ltd.]	Lospa or Bencox	2014-04-17
HWA Michael Van Der Woude [Corentec Co., Ltd.]	Lospa & Bencox	2014-04-17
HTX Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA or BENCOX	2014-04-17
PMN K132644 | MNI Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS	2013-10-31
PMN K132644 | MNH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS	2013-10-31
PMN K132644 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA IS	2013-10-31
PMN K132644 CORENTEC CO., LTD	LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU	2013-09-19
PMN K130673 | JWH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2013-04-24
PMN K130673 CORENTEC CO., LTD	LOSPA TOTAL KNEE REPLACEMENT SYSTEM	2013-04-15
NBH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2013-02-05
NBH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2013-02-05
HTW Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2013-02-05
HTW Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2013-02-05
HTO Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2013-02-05
HTO Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2013-02-05
PMN K122099 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-12-12
PMN K122099 | KWY Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-12-12
PMN K121665 | LZO Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-12-12
PMN K120924 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-12-12
PMN K120924 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX MIRABO	2012-12-12
PMN K122099 CORENTEC CO., LTD	BENCOX II STEM, BENCOX METAL HEAD	2012-10-05
PMN K121665 CORENTEC CO., LTD	BENCOX FORET & BENCOX DELTA	2012-09-25
PMN K120924 CORENTEC CO., LTD	BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG	2012-09-10
PMN K121037 | JWH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA Knee System	2012-05-15
PMN K121037 CORENTEC CO., LTD	LOSPA TIBIAL BASE PLATE	2012-05-03
PMN K110404 | JWH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2012-03-02
PMN K110404 CORENTEC CO., LTD	EAUM TOTAL KNEE SYSTEM	2012-02-16
LXH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2012-01-03
LXH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-01-03
HWT Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-01-03
HTJ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2012-01-03
HTJ Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2012-01-03
PMN K112019 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2011-10-26
PMN K112019 | KWY Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2011-10-26
PMN K112019 CORENTEC CO., LTD	BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP	2011-10-12
PMN K103431 | LPH Michael Van Der Woude [Corentec Co., Ltd.]	BENCOX	2011-07-29
PMN K103431 CORENTEC CO., LTD	COREN TOTAL HIP SYSTEM	2011-07-21
PMN K092076 | MNI Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2011-06-28
PMN K092076 | MNH Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2011-06-28
PMN K092076 | KWQ Michael Van Der Woude [Corentec Co., Ltd.]	LOSPA	2011-06-28
PMN K092076 CORENTEC CO., LTD	AEGIS & AEGIS II SPINAL SYSTEM	2010-04-02

Related Finance Registrations

NCAGE Code	SCTS3	CORENTEC CO., LTD.
CAGE Code	SCTS3	CORENTEC CO., LTD.