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	BBO-400A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-612D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-212D	FDA UDI	Class I	Active
Ezx	XTL60A	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB670	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-430A	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-220B	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA2	FDA UDI	Class I	Active
Zaguar	BRBHL-100	FDA UDI	Class I	Active
EZX Blade	XTB610	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-515	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB370NS	FDA UDI	Class I	Active
Ezx	EZX540	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-490	FDA UDI	Class I	Active
Ezx	XTR2-002	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	PBO-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-260B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NBA-178H	FDA UDI	Class I	Active
Imedicom Saw Blade	PMS-120B	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-210D	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-250C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-211	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-S02	FDA UDI	Class I	Active
EZX Blade	BRXTB470	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-700A	FDA UDI	Class I	Active
Brasseler EZX	BRITL053	FDA UDI	Class I	Active
MEDINAUT-Ix	MIX-CA1 / MIX-EX1T	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-220D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-412	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-430A	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU42	FDA UDI	Class II	Active
Leopard	ISA-100R	FDA UDI	Class I	Active
MEDINAUT-Ix	MIX-EX1B	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-970A	FDA UDI	Class I	Active
Ezx	ITL037	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-260A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSS-580D	FDA UDI	Class I	Active
EZX Blade	BRXTB520	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-240D	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-200D	FDA UDI	Class I	Active
Synth™ Standard	SYNTH-SSUD	FDA UDI	Class II	Active
Imedicom Saw Blade	BBO-210B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-401A	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB10	FDA UDI	Class II	Active
Synth™ Plus	SYNTH-SPU6	FDA UDI	Class II	Active
Imedicom Saw Blade	KSO-940C	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-910A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-260B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-250A	FDA UDI	Class I	Active

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