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 High Speed Blade	NSS-280	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-960C	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-210C	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB33	FDA UDI	Class II	Active
Imedicom Saw Blade	KLM-940D	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU36	FDA UDI	Class II	Active
Ezx	EZB100	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B1D1N10-20S	FDA UDI	Class II	Active
Ezx	BRXTL46B	FDA UDI	Class I	Active
Zaguar	BRMK-1000	FDA UDI	Class I	Active
Ezx	BRXTL63B	FDA UDI	Class I	Active
Ezx	XTH1000	FDA UDI	Class I	Active
Ezx	ELP040	FDA UDI	Class I	Active
Zaguar	BRBHC-100	FDA UDI	Class I	Active
IMEDICOM Saw Blade	XTB480NS	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 13	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSM-470D	FDA UDI	Class I	Active
Ezx	BRXTL61A	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB690	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-S01	FDA UDI	Class I	Active
Imedicom Saw Blade	PMO-110A	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-NP1	FDA UDI	Class I	Active
Imedicom Saw Blade	PBO-100A	FDA UDI	Class I	Active
B-Two Inflatable bone expander system balloon catheter	US102015	FDA UDI	Class II	Active
Imedicom High Speed Blade	NSP-515D	FDA UDI	Class I	Active
EZX Blade	BRXTB720	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU12	FDA UDI	Class II	Active
Imedicom High Speed Blade	NBA-178F	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-280C	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB17	FDA UDI	Class II	Active
Imedicom Saw Blade	BAO-440A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-940D	FDA UDI	Class I	Active
Ezx	EZX Kit 21	FDA UDI	Class I	Active
Ezx	EZS300	FDA UDI	Class I	Active
Brasseler EZX Blade	BRXTB650	FDA UDI	Class I	Active
Brasseler EZX	BRXST1000B	FDA UDI	Class I	Active
Ezx	EZX Kit 02	FDA UDI	Class I	Active
EZX Blade	XTB730	FDA UDI	Class I	Active
EZX Blade	XTB550	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB1-B1T1N10-15S	FDA UDI	Class I	Active
EZX Blade	XTB680	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-250A	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-401A	FDA UDI	Class I	Active
Ezx	BRXTL42A	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPU1-T2N5-20S	FDA UDI	Class II	Active
Brasseler EZX	BR EZX Kit 22	FDA UDI	Class I	Active
Imedicom Saw Blade	KLM-980B	FDA UDI	Class I	Active
Imedicom Saw Blade	SBN-710A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMS-950A	FDA UDI	Class I	Active
Zaguar	BH101S	FDA UDI	Class I	Active

IMEDICOM CO., LTD.

What IMEDICOM CO., LTD. makes

Frequently asked questions

Information

Catalogue (2877)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)