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
Ezx	XTL54B	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-950C	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-940A	FDA UDI	Class I	Active
Zaguar	XTS660	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-200A	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-740A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-230C	FDA UDI	Class I	Active
Ezx	BRXTL37A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-920A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-910C	FDA UDI	Class I	Active
Imedicom Saw Blade	KDS-980B	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-210B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-412D	FDA UDI	Class I	Active
Synth™ Bes	SYNTH-BESX	FDA UDI	Class II	Active
EZX Blade	BRXTB460	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB380NS	FDA UDI	Class I	Active
Imedicom Saw Blade	SBO-751A	FDA UDI	Class I	Active
Zaguar	BRMJ-3000	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-450A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-460A	FDA UDI	Class I	Active
Imedicom Saw Blade	PMO-110B	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB45	FDA UDI	Class II	Active
Ezx	BRXTL65A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-B1D1MN2-15	FDA UDI	Class II	Active
Imedicom Saw Blade	BPO-280A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-210C	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-240A	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CA1 / MIX-EX4B	FDA UDI	Class I	Active
Zaguar	XTS350	FDA UDI	Class I	Active
Imedicom Saw Blade	PAO-120A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-920A	FDA UDI	Class I	Active
Brasseler EZX	BRXTL58B	FDA UDI	Class I	Active
Ezx	XTL44B	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB20	FDA UDI	Class II	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B2MN2-20	FDA UDI	Class II	Active
Imedicom Saw Blade	BPO-431A	FDA UDI	Class I	Active
SPINAUT-Ix	IX1000	FDA UDI	Class I	Active
Ezx	EZX Kit 11	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-450A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-920B	FDA UDI	Class I	Active
Imedicom Saw Blade	KLT-910D	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-270C	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-230D	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-100 Series	FDA UDI	Class I	Active
Ezx	BRXTL39A	FDA UDI	Class I	Active
Epinaut	C31011315	FDA UDI	Class II	Active
Imedicom Saw Blade	BDS-250A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-250B	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB26	FDA UDI	Class II	Active
Ezx	BRELL063	FDA UDI	Class I	Active

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