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
Spinaut-S	MS0.4-7000	FDA UDI	Class II	Active
Brasseler EZX	BR EZX Kit 05	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-400A	FDA UDI	Class I	Active
Ezx	XTL64A	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-910D	FDA UDI	Class I	Active
Brasseler EZX	BRXTL40B	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-910B	FDA UDI	Class I	Active
Ezx	BRXTL41B	FDA UDI	Class I	Active
Zaguar	BHL-200	FDA UDI	Class I	Active
Ezx	EZX KIT 35	FDA UDI	Class I	Active
Brasseler EZX	BRXTL64B	FDA UDI	Class I	Active
Brasseler EZX	BREZX2-A01	FDA UDI	Class I	Active
Imedicom Saw Blade	Model-240 Series	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB37	FDA UDI	Class II	Active
Ezx	ITL065	FDA UDI	Class I	Active
Ezx	BRXTL50B	FDA UDI	Class I	Active
Imedicom Saw Blade	SBV-750A	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 04	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-250C	FDA UDI	Class I	Active
Imedicom Saw Blade	BSO-433A	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-470A	FDA UDI	Class I	Active
Imedicom Saw Blade	BLM-230B	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-250D	FDA UDI	Class I	Active
Ezx	BRXTL65A	FDA UDI	Class I	Active
Brasseler EZX	BRXTL63B	FDA UDI	Class I	Active
Brasseler EZX	BR EZX Kit 25	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB42	FDA UDI	Class II	Active
IMEDICOM Saw Blade	XTB440NS	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-280D	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-970A	FDA UDI	Class I	Active
Synth™ Plus	CDS-BI1/ CDS-BIC1	FDA UDI	Class II	Active
Zaguar	BRBDW-100	FDA UDI	Class I	Active
Imedicom Saw Blade	PPO-120A	FDA UDI	Class I	Active
Ezx	BRXTL54B	FDA UDI	Class I	Active
Imedicom Saw Blade	KAS-970C	FDA UDI	Class I	Active
Imedicom Saw Blade	BMS-240A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-220D	FDA UDI	Class I	Active
Ezx	BRXTL58B	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-410A	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-440A	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-930D	FDA UDI	Class I	Active
EZX Blade	BRXTB550	FDA UDI	Class I	Active
Imedicom Saw Blade	SBC-751A	FDA UDI	Class I	Active
Zaguar	BDD-100	FDA UDI	Class I	Active
Imedicom Saw Blade	KMO-920D	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-960A	FDA UDI	Class I	Active
Ezx	ELP049	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-514	FDA UDI	Class I	Active
Synth™ Cds	SYNTH-CDS-CAX1	FDA UDI	Class II	Active
Imedicom Saw Blade	PSO-120B	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)