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	BLT-200B	FDA UDI	Class I	Active
Ezx	XTL47B	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-970B	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-950A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-910C	FDA UDI	Class I	Active
Imedicom Saw Blade	SBS-761A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-910D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-680	FDA UDI	Class I	Active
Zaguar	BRBDD-100	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-710 Series	FDA UDI	Class I	Active
Ezx	ELP057	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-270A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-200D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-215	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-915D	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU44	FDA UDI	Class II	Active
Zaguar	BHC-400	FDA UDI	Class I	Active
Imedicom Saw Blade	PMO-100A	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-230D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-250A	FDA UDI	Class I	Active
Ezx	BRXTL49A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1T1MN2-15	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSR-380D	FDA UDI	Class I	Active
MEDINAUT-Ix	MIX-EX1D	FDA UDI	Class I	Active
Ezx	EZX Kit 06	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-950B	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-WP1	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-950A	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-EX2B	FDA UDI	Class I	Active
Ezx	BRXTL59B	FDA UDI	Class I	Active
Zaguar	BRAAM-03	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU41	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1D1N5-15S	FDA UDI	Class II	Active
Imedicom Saw Blade	BDO-240D	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-950A	FDA UDI	Class I	Active
Medinaut Max	BMA-P10	FDA UDI	Class I	Unknown
Imedicom High Speed Blade	NSR-290	FDA UDI	Class I	Active
Ezx	BRXTL46B	FDA UDI	Class I	Active
Brasseler EZX	BRXTL45A	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-700 Series	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU22	FDA UDI	Class II	Active
Imedicom Saw Blade	BAO-270B	FDA UDI	Class I	Active
MEDINAUT-X(IBE System)	IBE-15	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSR-510	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-260B	FDA UDI	Class I	Active
Ezx	XTL44A	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-B01	FDA UDI	Class I	Active

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