Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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BMKorea Co., Ltd.
  • Registration Date 2016-05-19
  • Hit 2435

[Company Information]
□ Name : BMKorea Co., Ltd.
□ Company CI : attachment 1
□ Website Address (URL) : www.bmkmedi.com
□ Location
○ Headquater : 58, Dangjeong-ro, Gunpo-si, Gyeonggi-do, Korea
○ Research Laboratory : Same as above
○ Factory 1 : Same as above
□ Contacts (URL)
○ Department : Head Office
○ Tel : +82 31 451 9294~5, Fax : +82 31 478 0788 ,
email : info@bmkmedi.com
□ Promotional Materials : attachment 2 (URL)

[Detailed Information]


□ Product 1
○ Model : GUARDIAN
○ Intended Use :
The GUARDIAN Inflatable Bone Expander System, PRIMER Inflatable Bone Expander System and GUARDIAN-SG Inflatable Bone Expander System are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebralaugmentation, such as kyphoplasty.
○ Image : attachment 3
○ Promotional Materials : attachment 4

□ Product 2
○ Model : Barclay
○ Intended Use :
The Barclay PMMA Bone Cement and the MUDLOCK PMMA Bone Cement are indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastratic cancers, myeloma).

□ Product 3
○ Model : SYNSTER® Pedicle Screw
○ Intended Use :
The SYNSTER® Pedicle Screw System and SYNSTER® PLUS Pedicle Screw System are a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The SYNSTER® Pedicle Screw System and SYNSTER® PLUS Pedicle ScrewSystem are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)

□ Product 4
○ Model : GALAXY MIS Screw System
○ Intended Use :
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
○ Image : attachment 3
○ Promotional Materials : attachment 4

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