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	NSR-212	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-900A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-772A	FDA UDI	Class I	Active
Ezx	BRXTL60A	FDA UDI	Class I	Active
EZX Blade	BRXTB560	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB350NS	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-240D	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-210C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-490D	FDA UDI	Class I	Active
Ezx	BRXST2000 Plus	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-270B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-220C	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-915C	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-200C	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-280B	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-920A	FDA UDI	Class I	Active
Imedicom Saw Blade	RLH-600A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-260C	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-B02	FDA UDI	Class I	Active
Ezx	XTL51A	FDA UDI	Class I	Active
Ezx	XTL56A	FDA UDI	Class I	Active
Ezx	ITL059	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB31	FDA UDI	Class II	Active
Imedicom Saw Blade	BMS-230D	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-980A	FDA UDI	Class I	Active
EZX Blade	BRXTB710	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-240A	FDA UDI	Class I	Active
Ezx	BRXTL39B	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-900B	FDA UDI	Class I	Active
Zaguar	AAM04	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-970D	FDA UDI	Class I	Active
Zaguar	BRHC-100	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-950A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSS-480D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-314	FDA UDI	Class I	Active
Synth™ Plus	PBES15	FDA UDI	Class II	Active
Synth™ Plus Bilateral	SYNTH-SPB	FDA UDI	Class II	Active
Imedicom Saw Blade	BAS-270A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-761A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSA-415D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-720A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-960B	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-940A	FDA UDI	Class I	Active
B-Two Vertebral Balloon Expand® Kyphoplasty System	US101015	FDA UDI	Class II	Active
EZX Blade	BRXTB600	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-380	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-480D	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-730A	FDA UDI	Class I	Active

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