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 High Speed Blade	NSA-511	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-960B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-250D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSS-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-270B	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-460A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-430A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-200D	FDA UDI	Class I	Active
Ezx	EZX2-A01	FDA UDI	Class I	Active
Ezx	XTL37A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-211D	FDA UDI	Class I	Active
Synth™ Bes	SYNTH BES10	FDA UDI	Class II	Unknown
EZX Blade	BRXTB580	FDA UDI	Class I	Active
Zaguar	BRBH-101S	FDA UDI	Class I	Active
Ezx	XTR2-001	FDA UDI	Class I	Active
Brasseler EZX	BREZH200	FDA UDI	Class I	Active
Imedicom Saw Blade	SBA-772A	FDA UDI	Class I	Active
Leopard	ISA-100W	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-920B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-210B	FDA UDI	Class I	Active
Ezx	BRXTL61B	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1T1N10-10S	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-940C	FDA UDI	Class I	Active
Ezx	BRXST1000TB2	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU46	FDA UDI	Class II	Active
Medinaut-V	IVP-NP1	FDA UDI	Class I	Active
MEDINAUT-Ix	MIX-CA1	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-930D	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-920C	FDA UDI	Class I	Active
Ezx	BRXTL49B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-210C	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-410A	FDA UDI	Class I	Active
Imedicom Saw Blade	PLM-140A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-750D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBM-770A	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-920D	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-980D	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-980B	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-930A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-580D	FDA UDI	Class I	Active
Ezx	ITL034	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB24	FDA UDI	Class II	Active
Ezx	BRXTLSA5865	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-420A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-980B	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-220B	EUDAMEDFDA UDI	Class I	Active
Imedicom Saw Blade	KBO-930C	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-920B	FDA UDI	Class I	Active
Synth™ Vrt	SYNTH-V150	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-401A	FDA UDI	Class I	Active

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