Bm Korea Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009475067
• FEI Number: 3009475067
• Name: BM KOREA CO., LTD.
• Owner & Operator: BM KOREA CO., LTD.
• Contact Address: 58, Dangjeong-ro ; Gunpo-si KR-41 Gyeonggido 15847 KR
• Official Correspondent:
  • Chang Hwa You
  • 82-31-4519294-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Importing Logistics Registration:
  • Importer: Globio S.A de C.V
  • Address: 417 Lechuguilla Court El Paso ; El Paso, TX 79912 UNITED STATES
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: JTS Distributing LLC
  • Address: 281 Cranston Ave. ; Carmel, IN 46032 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Vertebras Surgical LLC
  • Address: 1774 Mirrasou place ; San Jose, CA 95124 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: VEXIM, Inc
  • Address: 1251 Avenue of the Americas-3rd Fl ; Manhattan, NY 10020 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 58, Dangjeong-ro ; Gunpo-si Gyeonggido, 15847 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08809255544817 BM KOREA CO., LTD	GUARDIAN Inflatable Bone Expander System	2020-05-06
GUDID 08809255544633 BM KOREA CO., LTD	GUARDIAN-SG Inflatable Bone Expander System	2020-05-06
GUDID 08809255544213 BM KOREA CO., LTD	GUARDIAN Inflatable Bone Expander System	2020-05-06
GUDID 08809255544169 BM KOREA CO., LTD	GUARDIAN Inflatable Bone Expander System	2020-05-06
GUDID 08809255542707 BM KOREA CO., LTD	GUARDIAN Inflatable Bone Expander System	2020-05-06
GUDID 08809255540987 BM KOREA CO., LTD	GUARDIAN-SG Inflatable Bone Expander System	2020-05-06
PMN K143110 | NKB BM KOREA CO., LTD.	Phosmid MIS Screw System	2017-07-07
PMN K143110 | NKB BM KOREA CO., LTD.	GALAXY MIS Screw System	2017-07-07
PMN K143110 | NKB BM KOREA CO., LTD.	Amada MIS Screw System	2017-07-07
PMN K143110 | MNI BM KOREA CO., LTD.	Phosmid MIS Screw System	2017-07-07
PMN K143110 | MNI BM KOREA CO., LTD.	GALAXY MIS Screw System	2017-07-07
PMN K143110 | MNI BM KOREA CO., LTD.	Amada MIS Screw System	2017-07-07
PMN K143110 | MNH BM KOREA CO., LTD.	Phosmid MIS Screw System	2017-07-07
PMN K143110 | MNH BM KOREA CO., LTD.	GALAXY MIS Screw System	2017-07-07
PMN K143110 | MNH BM KOREA CO., LTD.	Amada MIS Screw System	2017-07-07
MJG BM KOREA CO., LTD.	GUARDIAN-SG BONE BIOPSY	2015-02-24
MJG BM KOREA CO., LTD.	GUARDIAN BONE BIOPSY	2015-02-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Osteo Introducer System	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Needle Cement Dispenser System	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Inflation Syringe	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Inflatable Bone Expander System	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Drill	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Bone Filler Device	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	GUARDIAN-SG Balloon Catheter	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	CAVIMEND Osteo Introducer System II	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	CAVIMEND Inflatable Bone Expander System II	2015-01-24
PMN K143006 | NDN BM KOREA CO., LTD.	CAVIMEND Bone Filler Device II	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Osteo Introducer System	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Needle Cement Dispenser System	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Inflation Syringe	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Inflatable Bone Expander System	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Drill	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Bone Filler Device	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	GUARDIAN-SG Balloon Catheter	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	CAVIMEND Osteo Introducer System II	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	CAVIMEND Inflatable Bone Expander System II	2015-01-24
PMN K143006 | HRX BM KOREA CO., LTD.	CAVIMEND Bone Filler Device II	2015-01-24
PMN K143006 BM KOREA CO., LTD.	GUARDIAN-SG Inflatable Bone Expander System	2015-01-16
GAD BM KOREA CO., LTD.	FBR(Flexible Blades Retractor)	2014-10-31
JDZ BM KOREA CO., LTD.	GUARDIAN-MD	2014-01-27
PMN K122518 | ODP BM KOREA CO., LTD.	TALON? TLIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	SYNSTER? TLIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	SYNSTER? PTLIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	SYNSTER? PLIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	SYNSTER? Cervical Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	SYNSTER? ALIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	RHEA? PLIF Cage	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	BMK TLIF Cage Instrument	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	BMK PLIF &PTLIF Cage Instrument	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	BMK Cervical Cage Instrument	2013-02-24
PMN K122518 | ODP BM KOREA CO., LTD.	BMK ALIF Cage Instrument	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	TALON? TLIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	SYNSTER? TLIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	SYNSTER? PTLIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	SYNSTER? PLIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	SYNSTER? Cervical Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	SYNSTER? ALIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	RHEA? PLIF Cage	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	BMK TLIF Cage Instrument	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	BMK PLIF &PTLIF Cage Instrument	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	BMK Cervical Cage Instrument	2013-02-24
PMN K122518 | MAX BM KOREA CO., LTD.	BMK ALIF Cage Instrument	2013-02-24
PMN K122518 BM KOREA CO., LTD.	SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE	2013-02-15
PMN K120353 | MNI BM KOREA CO., LTD.	SYNSTER? Pedicle Screw System Instrument	2012-05-23
PMN K120353 | MNI BM KOREA CO., LTD.	SYNSTER PEDICLE SCREW SYSTEM	2012-05-23
PMN K120353 | MNI BM KOREA CO., LTD.	GALAXY-DT	2012-05-23
PMN K120353 | MNI BM KOREA CO., LTD.	GALAXY-DT Instrument	2012-05-23
PMN K120353 | MNH BM KOREA CO., LTD.	SYNSTER? Pedicle Screw System Instrument	2012-05-23
PMN K120353 | MNH BM KOREA CO., LTD.	SYNSTER PEDICLE SCREW SYSTEM	2012-05-23
PMN K120353 | MNH BM KOREA CO., LTD.	GALAXY-DT	2012-05-23
PMN K120353 | MNH BM KOREA CO., LTD.	GALAXY-DT Instrument	2012-05-23
PMN K120353 BM KOREA CO., LTD.	SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM	2012-05-09
LXH BM KOREA CO., LTD.	TLIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? TLIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? PTLIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? PSS (Pedicle Screw System) Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? PLIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? Cervical Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	SYNSTER? ALIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	PLIF & PTLIF Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	Cervical Cage Instrument	2012-03-16
LXH BM KOREA CO., LTD.	ALIF Cage Instrument	2012-03-16
PMN K111820 | ODP BM KOREA CO., LTD.	SYNSTER? TLIF CAGE	2012-03-15
PMN K111820 | ODP BM KOREA CO., LTD.	SYNSTER? PTLIF CAGE	2012-03-15
PMN K111820 | ODP BM KOREA CO., LTD.	SYNSTER? PLIF CAGE	2012-03-15
PMN K111820 | ODP BM KOREA CO., LTD.	SYNSTER? CERVICAL CAGE	2012-03-15
PMN K111820 | ODP BM KOREA CO., LTD.	SYNSTER? ALIF CAGE	2012-03-15
PMN K111820 | ODP BM KOREA CO., LTD.	BMK ALIF Cage Instrument	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	SYNSTER? TLIF CAGE	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	SYNSTER? PTLIF CAGE	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	SYNSTER? PLIF CAGE	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	SYNSTER? CERVICAL CAGE	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	SYNSTER? ALIF CAGE	2012-03-15
PMN K111820 | MAX BM KOREA CO., LTD.	BMK ALIF Cage Instrument	2012-03-15
PMN K111820 BM KOREA CO., LTD.	SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE	2012-03-14
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Osteo Introducer System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Inflation Syringe	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Inflatable Bone Expander System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Drill	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Bone Filler Device	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Bone Access Needle	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	VerteMAX Balloon Catheter	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Osteo Introducer System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Inflation Syringe	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Inflatable Bone Expander System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Drill	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Bone Filler Device	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Bone Access Needle	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	GUARDIAN Balloon Catheter	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Osteo Introducer System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Inflation Syringe	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Inflatable Bone Expander System	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Drill	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Bone Filler Device	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Bone Access Needle	2011-12-09
PMN K111593 | NDN BM KOREA CO., LTD.	Cavimend Balloon Catheter	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Osteo Introducer System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Inflation Syringe	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Inflatable Bone Expander System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Drill	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Bone Filler Device	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Bone Access Needle	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	VerteMAX Balloon Catheter	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Osteo Introducer System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Inflation Syringe	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Inflatable Bone Expander System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Drill	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Bone Filler Device	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Bone Access Needle	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	GUARDIAN Balloon Catheter	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Osteo Introducer System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Inflation Syringe	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Inflatable Bone Expander System	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Drill	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Bone Filler Device	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Bone Access Needle	2011-12-09
PMN K111593 | HRX BM KOREA CO., LTD.	Cavimend Balloon Catheter	2011-12-09
PMN K111593 BM KOREA CO., LTD.	GUARDIAN INFLATABLE BONE EXPANDER SYSTEM	2011-11-18