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Bk Meditech, Co., Ltd.

FDA Regulatory Profile

Bk Meditech, Co., Ltd. has 0 FDA recalls, 2 inspections, 11 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 21, 2013 · VAI
Latest 510(k)
Aug 11, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances11Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 21, 2013Hwaseong, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3004176895
May 6, 2010Hwaseong, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3004176895

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K200981Mega Plus MIS Spine SystemAug 11, 2020
K183080Mega Plus Spine SystemDec 10, 2018
K173180Mega Plus Spine SystemMar 15, 2018
K140577INNESIS PEEK TL CAGEOct 1, 2014
K132483INNESIS PEEK CERVICAL CAGEApr 2, 2014
K120464INNESIS PEEK CAGEJan 18, 2013
K110426DYNA-EXTOR IINov 2, 2011
K090424DVX SPINE SYSTEMMay 14, 2009
K080876DVX SPINE SYSTEMJun 4, 2008
K072436MEGA SPINE SYSTEMNov 1, 2007
K061599PIN SCREWJul 26, 2006

FDA data resources