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
B-Two Inflatable bone expander system balloon catheter	US102020	FDA UDI	Class II	Active
Imedicom Saw Blade	KDS-970C	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	PIBE-10	FDA UDI	Class II	Active
Ezx	BRELP034	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-940D	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-270A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-280B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-280C	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-410A	FDA UDI	Class I	Active
Zaguar	BRBH.101S	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-970A	FDA UDI	Class I	Active
Ezx	BRELP065	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-390D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-900D	FDA UDI	Class I	Active
Medinaut-V	11G-150	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-314D	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-900A	FDA UDI	Class I	Active
EZX Blade	XTB400	FDA UDI	Class I	Active
Brasseler EZX	BRXTL48B	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU2-B1D1N5-20S	FDA UDI	Class II	Active
Brasseler EZX	BRITL063	FDA UDI	Class I	Active
Brasseler EZX	BRXTL41A	FDA UDI	Class I	Active
Imedicom High Speed Blade	NBA-178	FDA UDI	Class I	Active
Brasseler EZX	BRITL054	FDA UDI	Class I	Active
Spinaut-I	ID2000	FDA UDI	Class II	Active
Ezx	XTLSB5865	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-314D	FDA UDI	Class I	Active
Brasseler EZX	BRXTL65A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-200C	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B1D1MN2-15	FDA UDI	Class II	Active
Ezx	ELL042	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-950D	FDA UDI	Class I	Active
Brasseler EZX	BREZX500	FDA UDI	Class I	Active
Brasseler EZX	BRITL052	FDA UDI	Class I	Active
Ezx	BRXTL65B	FDA UDI	Class I	Active
Ezx	BR EZX Kit 09	FDA UDI	Class I	Active
Imedicom Saw Blade	PDS-120B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-270	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-420A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-950B	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-970C	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-450D	FDA UDI	Class I	Active
Ezx	BRXTL49B	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB740	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU5	FDA UDI	Class II	Active
MEDINAUT-I(ICD System)	MEDICOM-CD	FDA UDI	Class II	Active
Imedicom Saw Blade	BLM-210C	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-940C	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-980D	FDA UDI	Class I	Active
Medinaut-V	IVP-PU1	FDA UDI	Class I	Active

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