Bm Korea Co., Ltd. is one of 18589 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bm Korea Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: GUARDIAN-SG Inflatable Bone Expander System, SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE, SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
5
Total
5
Cleared
0
Denied
Bm Korea Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Marietta, US.
Historical record: 5 cleared submissions from 2011 to 2015. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Bm Korea Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bm Korea Co., Ltd.
5 devices
Cleared
Jan 16, 2015
GUARDIAN-SG Inflatable Bone Expander System
Orthopedic
88d
Cleared
Feb 15, 2013
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA...
Orthopedic
182d
Cleared
May 09, 2012
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
Orthopedic
93d
Cleared
Mar 14, 2012
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
Orthopedic
260d
Cleared
Nov 18, 2011
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
Orthopedic
164d