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-270B	FDA UDI	Class I	Active
Synth™ Cds	SYNTH-CDS-NDP1	FDA UDI	Class II	Active
Imedicom Saw Blade	BLT-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-433A	FDA UDI	Class I	Active
Brasseler EZX	BRITL048	FDA UDI	Class I	Active
Brasseler EZX	BREZX550	FDA UDI	Class I	Active
Ezx	BRXTL43B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-440A	FDA UDI	Class I	Active
Imedicom Saw Blade	PLT-120B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-270B	FDA UDI	Class I	Active
Ezx	BRXTL49A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-460A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-260A	FDA UDI	Class I	Active
Zaguar	XTS450	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-771A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-280C	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-280C	FDA UDI	Class I	Active
Ezx	XST1000TB1	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-200D	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B1D1N5-20S	FDA UDI	Class II	Active
Imedicom Saw Blade	BLT-470A	FDA UDI	Class I	Active
Zaguar	BC300	FDA UDI	Class I	Active
Imedicom Saw Blade	SBM-760A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-915D	FDA UDI	Class I	Active
Medinaut-V	MEDICOM-VP	FDA UDI	Class I	Active
LEOPARD Micro	MMD-100	FDA UDI	Class I	Active
Ezx	EZX2-S02	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-960A	FDA UDI	Class I	Active
Ezx	ITL058	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-900A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-550	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PIBE-B00	FDA UDI	Class II	Active
Imedicom Saw Blade	KLM-980C	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-960C	FDA UDI	Class I	Active
Spinaut-E	S2000	FDA UDI	Class II	Active
Imedicom Saw Blade	KSO-900D	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-940A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-910A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-920C	FDA UDI	Class I	Active
Imedicom Saw Blade	PMS-110B	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-120 Series	FDA UDI	Class I	Active
Imedicom Saw Blade	PLT-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-433A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-770A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-350D	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-980C	FDA UDI	Class I	Active
Brasseler EZX	BRXTLSB5865	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-200C	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-250C	FDA UDI	Class I	Active

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