BM KOREA CO., LTD

BM Korea Co., Ltd specializes in spinal fixation hardware and assistive medical devices. Their portfolio includes bone-screw internal spinal fixation systems, metallic spinal fusion cages for procedures like cervical, ALIF, PLIF, PTLIF, and TLIF, as well as a thoracic cage orthosis force meter. They also produce assistive devices such as a dynamic arm support system, lumbar spine orthoses, reusable non-mouldable first aid limb splints, and a single-use catheter/overtube balloon inflator. These devices are designed for spinal stabilization, surgical support, and patient mobility assistance.

BM Korea Co., Ltd is based in the US. Their devices are listed in the FDA 510(k) and UDI registries, which are key databases for tracking medical device submissions and compliance under US jurisdiction. These registries help ensure transparency and traceability of their products in the domestic market.

The devices produced by BM Korea Co., Ltd are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on the intended use and potential risk associated with each device type.

BM Korea Co., Ltd offers bone-screw internal spinal fixation systems, such as the SYNSTER Pedicle Screw System and SYNSTER Plus Pedicle Screw System, which are used to stabilize the spine during surgical procedures. These systems are designed for procedures like cervical, ALIF (Anterior Lumbar Interbody Fusion), PLIF (Posterior Lumbar Interbody Fusion), PTLIF (Posterolateral Lumbar Interbody Fusion), and TLIF (Transforaminal Lumbar Interbody Fusion). They help maintain spinal alignment and promote proper healing by securing vertebrae in place.

Yes, BM Korea Co., Ltd manufactures a reusable, non-mouldable first aid limb splint, which is designed for temporary immobilization of injured limbs in emergency or pre-hospital settings. This type of device helps stabilize fractures or dislocations until further medical treatment can be administered, reducing the risk of further injury during transport or waiting periods.