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	PMO-100J	FDA UDI	Class I	Active
Ezx	BR EZX Kit 12	FDA UDI	Class I	Active
Medinaut Max	BMA-R30	FDA UDI	Class I	Unknown
Ezx	XZT1000	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-650D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-711D	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-980B	FDA UDI	Class I	Active
Medinaut Max	BMA-D20-AP01	FDA UDI	Class I	Unknown
Imedicom Saw Blade	KDS-950D	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU24	FDA UDI	Class II	Active
LEOPARD Micro	BG-45	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B2MN2-20	FDA UDI	Class II	Active
Imedicom Saw Blade	KAO-910B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-980C	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-210A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-250A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-260A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-920A	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-920D	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-280B	FDA UDI	Class I	Active
MEDINAUT-Ix	MIX-CA1 / MIX-EX1D	FDA UDI	Class I	Active
Brasseler EZX	BRITL065	FDA UDI	Class I	Active
Zaguar	XTS550	FDA UDI	Class I	Active
Ezx	BR EZX Kit 27	FDA UDI	Class I	Active
Brasseler EZX	BREZB200	FDA UDI	Class I	Active
Brasseler EZX	BRITL043	FDA UDI	Class I	Active
Zaguar	BHL-400	FDA UDI	Class I	Active
Synth™ Standard	SYNTH-SSU	FDA UDI	Class II	Active
Ezx	XST1000TA2	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-B2N5-20S	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSA-680	FDA UDI	Class I	Active
EZX Blade	XTB410	FDA UDI	Class I	Active
Imedicom Saw Blade	PAO-120B	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1T1MN2-10	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-280C	FDA UDI	Class I	Active
Imedicom Saw Blade	PMS-100B	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-470A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-270C	FDA UDI	Class I	Active
Ezx	BRXST1000B	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-900B	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 07	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-230B	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-250B	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-450A	FDA UDI	Class I	Active
Medinaut-V	IVP-NF3	FDA UDI	Class I	Active
Ezx	BRELP040	FDA UDI	Class I	Active
Ezx	BRXTL50A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-930A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-900C	FDA UDI	Class I	Active

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