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
Synth™ Plus Bilateral	SYNTH-SPB36	FDA UDI	Class II	Active
EZX Blade	BRXTB640	FDA UDI	Class I	Active
MEDINAUT Plus Kyphoplasty System	MPB2-T2MN2-20	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-960D	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-910B	FDA UDI	Class I	Active
Brasseler EZX	BRXTL57B	FDA UDI	Class I	Active
Imedicom Saw Blade	BBO-250D	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-280	FDA UDI	Class I	Active
Imedicom Saw Blade	BLT-230A	FDA UDI	Class I	Active
EZX Blade	XTB740	FDA UDI	Class I	Active
Imedicom Saw Blade	KDO-900A	FDA UDI	Class I	Active
Imedicom Saw Blade	KBO-950D	FDA UDI	Class I	Active
MEDINAUT-Ix	ICD-CP1	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSP-550	FDA UDI	Class I	Active
Ezx	ELL051	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB35	FDA UDI	Class II	Active
Imedicom Saw Blade	Model-250 Series	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-970C	FDA UDI	Class I	Active
Imedicom Saw Blade	PLM-120A	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-940B	FDA UDI	Class I	Active
Imedicom Saw Blade	SBL-730A	FDA UDI	Class I	Active
Ezx	BRXTL44A	FDA UDI	Class I	Active
Imedicom Saw Blade	BDS-210A	FDA UDI	Class I	Active
Imedicom Saw Blade	KSO-930A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-200B	FDA UDI	Class I	Active
Imedicom High Speed Blade	NSR-615	FDA UDI	Class I	Active
Ezx	EZX570	FDA UDI	Class I	Active
Imedicom Saw Blade	KAO-920D	FDA UDI	Class I	Active
Imedicom Saw Blade	BPO-200A	FDA UDI	Class I	Active
Zaguar	BRBHL-100	FDA UDI	Class I	Active
Imedicom Saw Blade	BDO-210A	FDA UDI	Class I	Active
Ezx	BREZS300	FDA UDI	Class I	Active
Ezx	XTL37B	FDA UDI	Class I	Active
Zaguar	XTS420	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-940A	FDA UDI	Class I	Active
Imedicom Saw Blade	BAS-270D	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB18	FDA UDI	Class II	Active
Zaguar	AAM03	FDA UDI	Class I	Active
Imedicom Saw Blade	BAO-210C	FDA UDI	Class I	Active
Imedicom Saw Blade	KPO-900C	FDA UDI	Class I	Active
Synth™ Plus	SYNTH-SPU14	FDA UDI	Class II	Active
EZX Blade	BRXTB740	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-440A	FDA UDI	Class I	Active
Brasseler EZX	BRXTL55B	FDA UDI	Class I	Active
Ezx	BRXTL40A	FDA UDI	Class I	Active
Imedicom Saw Blade	BSN-280B	FDA UDI	Class I	Active
Imedicom Saw Blade	BMO-480A	FDA UDI	Class I	Active
Synth™ Plus Bilateral	SYNTH-SPB38	FDA UDI	Class II	Active
Imedicom Saw Blade	BDO-210D	FDA UDI	Class I	Active
Zaguar	BRMJ-1000	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)