Question 1

What types of medical devices does IMEDICOM CO., LTD. manufacture?

Accepted Answer

IMEDICOM CO., LTD. specializes in surgical instruments and power tools for orthopaedic and bone procedures. Their product range includes single-use surgical saw blades (both sagittal and reciprocating), orthopaedic osteotome blades, sawing attachments for power tools, rechargeable battery-powered handpieces, electric motors for bone/joint surgery, and kits for balloon kyphoplasty and orthopaedic cement preparation. These devices are designed to assist in precise cutting, shaping, and cement delivery during surgical interventions.

Question 2

Where is IMEDICOM CO., LTD. based?

Accepted Answer

IMEDICOM CO., LTD. is headquartered in the United States. Their location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for devices intended for the U.S. market or global distribution.

Question 3

Which regulatory registries or databases list IMEDICOM CO., LTD.’s devices?

Accepted Answer

IMEDICOM CO., LTD.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model names, and regulatory classifications.

Question 4

How are IMEDICOM CO., LTD.’s devices classified under FDA regulations?

Accepted Answer

IMEDICOM CO., LTD.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as bone or joint procedures.

Question 5

What distinguishes IMEDICOM CO., LTD.’s single-use devices from their reusable counterparts?

Accepted Answer

IMEDICOM CO., LTD. offers single-use surgical saw blades and osteotome blades, which are designed for one-time use only. Single-use devices eliminate the need for sterilization between patients, reducing the risk of cross-contamination and ensuring consistent performance. This approach is particularly critical in orthopaedic surgery, where precision and sterility are paramount, as it simplifies inventory management and compliance with infection control protocols.

Device	Model / Reference	Registries	Class	Status
Imedicom Saw Blade	KPO-900B	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-930B	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB730	FDA UDI	Class I	Active
EZX Blade	XTB470	FDA UDI	Class I	Active
Zaguar	BRBC-300	FDA UDI	Class I	Active
Brasseler EZX	BRITL056	FDA UDI	Class I	Active
Ezx	BRXTL47A	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB470NS	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB620	FDA UDI	Class I	Active
Ezx	BR EZX Kit 03	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-214D	FDA UDI	Class I	Active
EZX Blade	BRXTB660	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU2-B2N5-15S	FDA UDI	Class II	Active
MEDINAUT-X(IBE System)	IBE-B00	FDA UDI	Class II	Active
Ezx	BREZS200	FDA UDI	Class I	Active
Imedicom Saw Blade	PSN-100B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-211	FDA UDI	Class I	Active
Ezx	BRXST1000TA3	FDA UDI	Class I	Active
Ezx	BR EZX Kit 05	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-920D	FDA UDI	Class I	Active
Spinaut-S	MS0.7-10000	FDA UDI	Class II	Active
Synth™ Plus	SYNTH-SPU25	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPU2-B1D1MN2-20	FDA UDI	Class II	Active
Brasseler EZX	BRITL049	FDA UDI	Class I	Active
Ezx	XTLSA3757	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-260D	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-280B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-260D	FDA UDI	Class I	Active
Brasseler EZX	BRXST2000M	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-910D	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU7	FDA UDI	Class II	Active
Imedicom Saw Blade	BDO-280B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-214D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-614D	FDA UDI	Class I	Active
Zaguar	BRAAM.02	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-570	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-580D	FDA UDI	Class I	Active
Zaguar	BRMJ.1000	FDA UDI	Class I	Active
Ezx	EZG101	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU29	FDA UDI	Class II	Active
Ezx	BRXTL58A	FDA UDI	Class I	Active
Imedicom Saw Blade	PDO-120B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-315D	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB28	FDA UDI	Class II	Active
EZX Blade	XTB600	FDA UDI	Class I	Active
Ezx	ELL043	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB360NS	FDA UDI	Class I	Active
Imedicom Saw Blade	PSN-120B	FDA UDI	Class I	Active
Zaguar	BRBDD.100	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-250A	FDA UDI	Class I	Active

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