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Data / Medical devices / South Korea / BK Meditech Co., Ltd.

BK Meditech Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 12 510(k) clearances

BK Meditech Co., Ltd. is registered with the FDA (registration 3004176895) in Hwaseong-si Gyeonggi, South Korea. It lists 26 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 11, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3004176895
Address
58, Eunhaengnamu-ro, Yanggam-myeon, Hwaseong-si Gyeonggi, South Korea, 18633
Owner or operator
BK MEDITECH CO., LTD. (9059102)
Roles
Contract manufacturer, Manufacturer
First device listed
July 26, 2006
Registered through
2026
Brand names listed
3.5MM FINAL TIGHTENER, 4 SIDED I-RATCHET HANDLE, ALIGNMENT DRIVER, ANTI TORQUE, ANTI TORQUE DRIVER, ANTI TORQUE HANDLE, ANTI TORQUE SLEEVE, AWL and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 11, 2020K200981Mega Plus MIS Spine SystemNKBSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
December 10, 2018K183080Mega Plus Spine SystemNKBSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
March 15, 2018K173180Mega Plus Spine SystemNKBSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
October 1, 2014K140577INNESIS PEEK TL CAGEMAXSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
April 2, 2014K132483INNESIS PEEK CERVICAL CAGEODPSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
January 18, 2013K120464INNESIS PEEK CAGEMAXSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
January 8, 2013K123476MEGA 5.5 SPINE SYSTEMMNHSubstantially EquivalentLsk Biopartners, Inc.accessdata.fda.gov
November 2, 2011K110426DYNA-EXTOR IIKTTSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
May 14, 2009K090424DVX SPINE SYSTEMMNHSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
June 4, 2008K080876DVX SPINE SYSTEMMNHSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
November 1, 2007K072436MEGA SPINE SYSTEMMNISubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov
July 26, 2006K061599PIN SCREWJDWSubstantially EquivalentBk Meditech, Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.