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
MEDINAUT-Ix	ICD-EX3D	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-940A	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB19	FDA UDI	Class II	Active
Zaguar	BRBC.300	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-T2N5-15S	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPB1-T2N10-15S	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PICD-CP1/ PICD-CFS1	FDA UDI	Class II	Active
EZX Blade	BRXTB610	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-240B	FDA UDI	Class I	Active
Zaguar	BRAAM-02	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-210D	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-220D	FDA UDI	Class I	Active
Ezx	XTL49B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-200A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-615	FDA UDI	Class I	Active
Mixing Bowl	MXB001	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB40	FDA UDI	Class II	Active
EZX Blade	XTB450	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-940A	FDA UDI	Class I	Active
EZX Blade	XTB350	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-200 Series	FDA UDI	Class I	Active
EZX Blade	BRXTB650	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-761A	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB740	FDA UDI	Class I	Active
Brasseler EZX	BREZS200	FDA UDI	Class I	Active
Ezx	EZX Kit 09	FDA UDI	Class I	Active
Imedicom Saw Blade	PBO-110B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-900A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-615	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 06	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU9	FDA UDI	Class II	Active
Imedicom Saw Blade	KMS-950B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-270A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBA-770A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-200B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-900B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-910C	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-940C	FDA UDI	Class I	Active
Ezx	EZX2-A02	FDA UDI	Class I	Active
Brasseler EZX	BRITL044	FDA UDI	Class I	Active
Ezx	XTL49A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-390	FDA UDI	Class I	Active
Imedicom Saw Blade	PMO-140A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-915B	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-970A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-910C	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-915D	FDA UDI	Class I	Active
Ezx	XTL60B	FDA UDI	Class I	Active
Brasseler EZX	BRITL3465	FDA UDI	Class I	Active

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