연혁

HISTORY

• 2020.

  Aug

  Cleared by FDA 510(k) (Mega Plus MIS Spine, No.K200981)

• 2018.

  Dec

  Cleared by FDA 510(k) (Mega Plus Spine, No.K183080)

  Mar

  Cleared by FDA 510(k) (Mega Plus Spine, No.K173180)

• 2016.

  Mar

  Exhibition on devices of the AAOS in Orlando, USA

• 2015.

  Nov

  Exhibition on devices of the COA in Chongqing, China

  Mar

  Exhibition on devices of the AAOS in Las Vegas, USA

• 2014.

  Nov

  Exhibition on devices of the COA in Beijing, China

  Oct

  Cleared by FDA 510(K) for the INNESIS TL Cage

  Mar

  Cleared by FDA 510(K) for the INNESIS PEEK Cervical Cage

  Mar

  Exhibition on devices of the AAOS in New Orleans, USA

• 2013.

  Nov

  Approved by CE Marketing for the INNESIS PEEK CERVICAL CAGE

  Apr

  Expanded to export (Mexico, Colombia)

  Mar

  Exhibition on devices of the AAOS in Chicago, USA

  Jan

  Cleared by FDA 510(K) for the INNESIS PEEK Cage

  Jan

  Cleared by FDA 510(K) for the Mega 5.5 Spine System

• 2012.

  Nov

  Exhibition on devices of the COA in Beijing, China

  Sep

  Launched Dyna-EXTOR|| in Brazil

  Feb

  Exhibition on devices of the AAOS in San Francisco, USA

  Feb

  Expanded to export(Iran, Canada)

• 2011.

  Nov

  Cleared by FDA 501(k) for the Dyna-EXTOR|| (K110426)

  Sep

  Approved by CE Marketing for the INNESIS PEEK Cage

  Apr

  Approved by CE Marketing for the INNESIS Cage

  Feb

  Exhibition on devices of the AAOS in San Diego, USA

• 2010.

  Nov

  Exhibition on devices of the COA in Chengdu, China

• 2009.

  Dec

  Approved by CE Marketing for the Dyna-EXTOR||

  Apr

  Cleared by FDA 510(k) for the DVX 5.5 Spine system (K090424)

• 2008.

  Apr

  FDA device listing for Haki Knife

  Jun

  Cleared by FDA 510(k) for the DVX Spine System (K080876)

• 2007.

  Nov

  Cleared by FDA 510(k) for the MEGA Spine System(K072436)

  Mar

  Certified KGMP by KFDA

• 2006.

  Jul

  Cleared by FDA 510(k) for the Pin Screw(K061599)

• 2005.

  Apr

  Launched Mega in Vietnam, Thailand, Turkey, U.S.A, Malaysia and Greece

• 2004.

  Feb

  Launched Mega and Dyna-Extor in China and Japan

• 2003.

  Oct

  Approved by KT Mark for the 4-Bar Intelligent Knee(AL-73100)(KITA)

• 2002.

  Apr

  Approved CE Marking for Dyna Spine and Dyna-Extor(SM)-wrist

  Apr

  Certified ISO 13485 Quality system(DNV)

• 2001.

  Dec

  Enrolled Company for the military service(Industrial Technical Personnel)

• 2000.

  Aug

  Approved by ISO 9001 & KS A9001 standard(KTL)

  May

  Established "BK MEDITECH TECHNICAL INSTITUE"(KOTIA)

  Mar

  Renamed as BK MEDITECH Co.,Ltd.

• 1999.

  Apr

  Certified permission for Manufactured Article of SPINE System

• 1998.

  Oct

  Moved to a new factory in Hwasung-Si, Kyunggi-Do

• 1996.

  May

  Company established "HYUP CHIN MEDICAL Co.,Ltd."

• 1995.

  Oct

  The second certified permission for manufactured articles(Dyna Extor, Pin Screw) by Korean government

• 1993.

  Oct

  Started the R&D for Dyna Extor

• 1992.

  Aug

  The first certified permission for manufactured articles(EXTOR) by Korean government

• 1989.

  Oct

  R&D of EXTOR with Seoul Univ. and KIST

  Mar

  The defense industry(precision fuze development, manufacturing) and Started the R&D project of medical devices(External Fixator System)