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
Epinaut	C60011315	FDA UDI	Class II	Active
Imedicom Saw Blade	BSO-220D	FDA UDI	Class I	Active
Zaguar	XTS400	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-980C	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-EX2D	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-420A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NBA-118	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA1 / MIX-EX4D	FDA UDI	Class I	Active
EZX Blade	XTB500	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-950A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-250B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-230A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-960D	FDA UDI	Class I	Active
Spinaut-V	V3000	FDA UDI	Class II	Active
Imedicom Saw Blade	BAS-210B	FDA UDI	Class I	Active
MEDINAUT Kyphoplasty System	MKB10	FDA UDI	Class II	Active
Synth™ Plus	SYNTH-SPU47	FDA UDI	Class II	Active
Ezx	XST2000M	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB1	FDA UDI	Class II	Active
Spinaut-V	V1000	FDA UDI	Class II	Active
Imedicom Saw Blade	BLT-210A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-460A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-200B	FDA UDI	Class I	Active
Ezx	EZG100	FDA UDI	Class I	Active
Ezx	BRELR00150	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-771A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-900B	FDA UDI	Class I	Active
Ezx	BRXTL45A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-710A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-910A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-771A	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU30	FDA UDI	Class II	Active
EZX Blade	BRXTB590	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-900C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-580	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-270D	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB720	FDA UDI	Class I	Active
Brasseler EZX	BRITL051	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-220C	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-710A	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-915D	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-980A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBS-760A	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU15	FDA UDI	Class II	Active
Imedicom Saw Blade	BPO-250C	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-410A	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB340NS	FDA UDI	Class I	Active
Ezx	XTL43A	FDA UDI	Class I	Active
EZX Blade	XTB370	FDA UDI	Class I	Active
Imedicom Saw Blade	RST-610A	FDA UDI	Class I	Active

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