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	KAO-915B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-260A	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-200D	FDA UDI	Class I	Active
Ezx	BRXTL64A	FDA UDI	Class I	Active
Ezx	BR EZX Kit 10	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU13	FDA UDI	Class II	Active
Ezx	XTL53B	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-960B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-670D	FDA UDI	Class I	Active
Ezx	EZX520	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-960B	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU	FDA UDI	Class II	Active
Ezx	BRXZT1000	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-240C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-250	FDA UDI	Class I	Active
Spinaut-E	E2000	FDA UDI	Class II	Active
Imedicom Saw Blade	KPO-900A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-980C	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-430A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-515D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBO-772A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-511D	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PICD-CA2/ PICD-NDT2	FDA UDI	Class II	Active
Brasseler EZX	BRXTL64A	FDA UDI	Class I	Active
Ezx	BR EZX Kit 16	FDA UDI	Class I	Active
Ezx	XTL43B	FDA UDI	Class I	Active
Ezx	ELP041	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU2-B1T1MN2-15	FDA UDI	Class II	Active
Imedicom Saw Blade	BSO-210C	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-200B	FDA UDI	Class I	Active
Ezx	BRXTL37B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-440A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-930D	FDA UDI	Class I	Active
Ezx	ELP045	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-740A	FDA UDI	Class I	Active
Imedicom Saw Blade	PDO-120A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-270D	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-900B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-250D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-310	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-512D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-900B	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1D1MN2-15	FDA UDI	Class II	Active
Imedicom Saw Blade	PAS-110A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-431A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-200C	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-280D	FDA UDI	Class I	Active
Ezx	XTL41A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-915D	FDA UDI	Class I	Active
Ezx	XTL46B	FDA UDI	Class I	Active

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