FDA.reportPublic FDA data

BK MEDITECH CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041768953004176895BK MEDITECH CO., LTD.1N2026-01-0158, Eunhaengnamu-ro, Yanggam-myeon Hwaseong-si Gyeonggi KR 18633

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
627041890425311K200981Mega Plus MIS Spine SystemNKB2020-08-11
627042045774743K183080Mega Plus Spine SystemNKB2018-12-10
627041129601903K173180Mega Plus Spine SystemNKB2018-03-15
627042031785998K140577INNESIS PEEK TL CAGEMAX2014-10-01
627041070316511K132483INNESIS PEEK CERVICAL CAGEODP2014-04-02
627041830133225K123476MEGA 5.5 SPINE SYSTEMMNH2013-01-08
627041829766072K120464INNESIS PEEK CAGEMAX2013-01-18
627041494594691K110426DYNA-EXTOR IIKTT2011-11-02
627041381685619K090424DVX SPINE SYSTEMMNH2009-05-14
627041563667216K080876DVX SPINE SYSTEMMNH2008-06-04
627041496331078K072436MEGA SPINE SYSTEMMNI2007-11-01
627041005109702K061599PIN SCREWJDW2006-07-26
627041151315645
627041167236857
627041210887434
627041241433595
627041382984640
627041392503472
627041407029894
627041491144019
627041517718888
627041542750828
627041554787788
627041667978376
627041820340521
627041857339500
627041915629379
627041943104303
627041943886237
627041945292944
627042072233488

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB32020-08-11
MNH32013-01-08
MAX22014-10-01
ODP12014-04-02
KTT12011-11-02
MNI12007-11-01
JDW12006-07-26

PMN#