Bk Meditech Co L T D

FDA Filings

This page includes the latest FDA filings for Bk Meditech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004176895
FEI Number3004176895
NameElaine Duncan
Owner & OperatorBK MEDITECH CO., LTD.
Contact Address58, Eunhaengnamu-ro, Yanggam-myeon --
Hwaseong-si KR-41 Gyeonggido 18633 KR
Official Correspondent
  • BYOUNGJUN - PARK
  • 82-31-3529135-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
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BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK MEDITECH CO.,LTD.
 PIN SCREW 2023-09-18
BK Meditech, Co., Ltd
Mega Plus MIS Spine System2020-08-11
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA PLUS SPINE SYSTEM2019-09-20
BK Meditech Co., Ltd
Mega Plus Spine System2018-12-10
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA PLUS SPINE SYSTEM2018-03-18
BK MEDITECH Co., Ltd.
Mega Plus Spine System2018-03-15
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK TL CAGE2014-11-04
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK CERVICAL CAGE2014-11-04
Elaine Duncan [BK MEDITECH CO., LTD.]
BALL CURETTE2014-11-04
BK MEDITECH CO., LTD.
INNESIS PEEK TL CAGE2014-10-01
BK MEDITECH CO., LTD.
INNESIS PEEK CERVICAL CAGE2014-04-02
Elaine Duncan [BK MEDITECH CO., LTD.]
WRENCH 3.0(3.0MM HEX)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER T-WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH(5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH(4.5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(BT30)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(BT20)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(4.5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DUAL LOCKING WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DOUBLE STARTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
3.5MM FINAL TIGHTENER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT IMPACTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
INSERTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT INSERTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
CURVED IMPACTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
SHAVER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
RASP2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
ROOT RETRACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DURA RETRACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
LONG-ARM BREAKER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
SURGICAL INSTRUMENT TRAY2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA5.5 SPINE SYSTEM2013-03-13
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA5.5 SPINE SYSTEM2013-03-13
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK CAGE2013-03-13
BK MEDITECH CO., LTD.
INNESIS PEEK CAGE2013-01-18
Elaine Duncan [BK MEDITECH CO., LTD.]
Dyna-EXTOR II External Fixation System2012-07-02
BK MEDITECH CO., LTD.
DYNA-EXTOR II2011-11-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX5.5 SPINE SYSTEM2009-11-25
BK MEDITECH CO., LTD.
DVX SPINE SYSTEM2009-05-14
Elaine Duncan [BK MEDITECH CO., LTD.]
TRIAL2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
TESTER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
T-TYPE RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SQ-ADAPTER HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SPINNER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SPANNER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SC REDUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROTATION TUBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROTATION HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD GRIPPER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
RIGHT MARKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
RELEASE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCTION INTRODUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER STICK2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
PERSUADER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MINI T-RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LEFT MARKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LARGE T-TORQUE HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
I-TYPE RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GUIDE PIN(R)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GUIDE PIN(L)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT CASE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
EXTRACTOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTION SCREW2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DEROTATOR HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DEROTATION CLIP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
CLIP WRENCH2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
CAGE SUPPORT2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BONE FILLER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BALL POINT TESTER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ANTI TORQUE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ANTI TORQUE DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
4 SIDED I-RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
TURNBUCKLE DRIVER-FIXED2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MULTI-AXIAL LONG-ARM SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MULTI SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MONO SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LONG-ARM SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
INTERMEDIATE SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ILIAC SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTION SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ALIGNMENT DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD BENDER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
FRENCH ROD BENDER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD ROCKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD PUSHER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD INTRODUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD FORCEPS2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
POWER ROD FORCEPS2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT PROBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT PROBE(LENKE)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BENT PROBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BENT PROBE(LENKE)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
9.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
8.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
7.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
7.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
6.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
6.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
5.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
5.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
4.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
3.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
10.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
COMPRESSOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
AWL2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX SPINE SYSTEM2008-07-01
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX SPINE SYSTEM2008-07-01
BK MEDITECH CO., LTD.
DVX SPINE SYSTEM2008-06-04
Elaine Duncan [BK MEDITECH CO., LTD.]
HAKI Knife2008-04-29
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA SPINE SYSTEM2008-01-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA SPINE SYSTEM2008-01-02
BK MEDITECH CO., LTD.
MEGA SPINE SYSTEM2007-11-01
BK MEDITECH CO., LTD.
PIN SCREW2006-07-26
Elaine Duncan [BK MEDITECH CO., LTD.]
PIN SCREW2006-07-26

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