Question 1

What types of medical devices does BM Korea Co., Ltd manufacture?

Accepted Answer

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.

Question 2

Where is BM Korea Co., Ltd based, and which regulatory registries list their devices?

Accepted Answer

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.

Question 3

How are the devices manufactured by BM Korea Co., Ltd classified under FDA regulations?

Accepted Answer

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.

Question 4

What kinds of spinal fixation systems does BM Korea Co., Ltd offer, and how are they used?

Accepted Answer

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.

Question 5

Are any of BM Korea Co., Ltd’s devices intended for emergency or first aid use?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Galaxy Mis Screw System	GC300-5595	FDA UDI	Class II	Active
Synster Pedicle Screw System Synster Plus Pedicle Screw System	A1P1-5540	FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	ST0935	FDA UDI	Class II	Active
Guardian Supporter	GAK-XL	FDA UDI	Class I	Active
Galaxy Mis Screw System	GB300-5580	FDA UDI	Class II	Active
Synster Pedicle Screw System Synster Plus Pedicle Screw System	A1P1-7550	FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	SPT1228	FDA UDI	Class II	Active
Galaxy Mis Screw System	GXMS-7540	FDA UDI	Class II	Active
Galaxy Mis Screw System	GB300-5520	FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	TT1526	FDA UDI	Class II	Active
Synster Pedicle Screw System Synster Plus Pedicle Screw System	A300-5513	FDA UDI	Class II	Active
Galaxy Mis Screw System	GB300-5517	FDA UDI	Class II	Active
Guardian Supporter	GCSET-XL	FDA UDI	Class I	Active
Galaxy Mis Screw System	GB300-5516	FDA UDI	Class II	Active
Galaxy Mis Screw System	GB300-5540	FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	SPT0828	FDA UDI	Class II	Active
Guardian Supporter	GAK-L	FDA UDI	Class I	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	TT1535	FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	TT1035	FDA UDI	Class II	Active
Galaxy Mis Screw System	GXMS-7535	FDA UDI	Class II	Active
Guardian Splint	GSACU-SR	FDA UDI	Class I	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif	TT1532	FDA UDI	Class II	Active
Guardian Supporter	GLSO-L	FDA UDI	Class I	Active
Galaxy Mis Screw System	GXMS-7545	FDA UDI	Class II	Active
Guardian Splint	GSL-S	FDA UDI	Class I	Active
Guardian Supporter	GLSO-XL	FDA UDI	Class I	Active
Guardian Supporter	GLSO-S	FDA UDI	Class I	Active
Guardian Splint	GSACU-LL	FDA UDI	Class I	Active
Guardian Supporter	GWT-S	FDA UDI	Class I	Active
Guardian Splint	GLL	FDA UDI	Class I	Active
Guardian Supporter	GAK-S	FDA UDI	Class I	Active
Guardian Splint	GSACU-LR	FDA UDI	Class I	Active
GALAXY MIS Screw System	K143110	FDA 510(k)FDA UDI	Class II	Active
Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa Cage	K122518	FDA 510(k)	Class II	Active
GUARDIAN-SG Inflatable Bone Expander System	K143006	FDA 510(k)	Class II	Active
Guardian Inflatable Bone Expander System	K111593	FDA 510(k)	Class II	Active
Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage	K111820	FDA 510(k)	Class II	Active
Synster Pedicle Screw System Synster Plus Pedicle Screw System	K120353	FDA 510(k)FDA UDI	Class II	Active

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