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	BPO-230A	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU23	FDA UDI	Class II	Active
Zaguar	BHC-200	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-980C	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-400A	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-980B	FDA UDI	Class I	Active
Ezx	BR EZX Kit 04	FDA UDI	Class I	Active
Imedicom Saw Blade	PSO-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-960B	FDA UDI	Class I	Active
Leopard	ISA-100D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-200B	FDA UDI	Class I	Unknown
Imedicom Saw Blade	KDS-915D	FDA UDI	Class I	Active
Imedicom Saw Blade	PLM-140B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-280D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-712	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-250B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-980B	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-920B	FDA UDI	Class I	Active
Leopard	ISA-100DM	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-920A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBS-730A	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-600 Series	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU8	FDA UDI	Class II	Active
Imedicom Saw Blade	KMO-960A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-210B	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-760A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-980A	FDA UDI	Class I	Active
Epinaut	L33013820	FDA UDI	Class II	Active
Imedicom Saw Blade	BSO-230A	FDA UDI	Class I	Active
Synth™ Plus	CDS-CP1/ CDS-CF1	FDA UDI	Class II	Active
Zaguar	BAO-100	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-900C	FDA UDI	Class I	Active
Ezx	ELP034	FDA UDI	Class I	Active
Imedicom Saw Blade	SBA-751A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-230C	FDA UDI	Class I	Unknown
Brasseler EZX	BRXTL60B	FDA UDI	Class I	Active
Ezx	BRELL038	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-240A	FDA UDI	Class I	Active
Ezx	BRXTL47A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-900D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-590	FDA UDI	Class I	Active
Ezx	XTL57B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-670	FDA UDI	Class I	Active
Zaguar	BRBDR-100	FDA UDI	Class I	Active
Imedicom Saw Blade	PDO-110A	FDA UDI	Class I	Active
Imedicom Saw Blade	PLT-110B	FDA UDI	Class I	Active
Imedicom Saw Blade	PSO-110B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-940B	FDA UDI	Class I	Active
Ezx	BRELL042	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-430A	FDA UDI	Class I	Active

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