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	KLM-960C	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B2MN2-20	FDA UDI	Class II	Active
Imedicom Saw Blade	BLM-270A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-280B	FDA UDI	Class I	Active
Ezx	ELL039	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B1T1MN2-10	FDA UDI	Class II	Active
Imedicom Saw Blade	KAS-950D	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-L01	FDA UDI	Class I	Active
Ezx	XTL48B	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-970B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-910B	FDA UDI	Class I	Active
Brasseler EZX	BREZS101	FDA UDI	Class I	Active
Ezx	BRXTL55A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-770A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	PLM-100J	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-240C	FDA UDI	Class I	Active
EZX Blade	BRXTB710	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-910C	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-200A	FDA UDI	Class I	Active
Imedicom Saw Blade	SMO-820A	FDA UDI	Class I	Unknown
Ezx	ITL051	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-220A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1D1MN2-20	FDA UDI	Class II	Active
Imedicom Saw Blade	PLM-110B	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 32	FDA UDI	Class I	Active
Brasseler EZX	BRXTL51B	FDA UDI	Class I	Active
Brasseler EZX	BRXZT1000	FDA UDI	Class I	Active
Medinaut Max	BMK-100	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-450A	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU45	FDA UDI	Class II	Active
Imedicom Saw Blade	PMO-120J	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1T1N10-15S	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-915C	FDA UDI	Class I	Active
Brasseler EZX	BRXTL38A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-950D	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-401A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-460A	FDA UDI	Class I	Active
Ezx	EZX501	FDA UDI	Class I	Active
Ezx	BRXTL44A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-270D	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-980B	FDA UDI	Class I	Active
Epinaut	C60013815	FDA UDI	Class II	Active
Ezx	ELL054	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-450A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-411	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-970C	FDA UDI	Class I	Active
Medinaut Max	BHL-400	FDA UDI	Class I	Active
Ezx	XTL52A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-240B	FDA UDI	Class I	Active

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