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Sign in to claim this brandIMEDICOM CO., LTD.
US
Last updated May 23, 2026
What IMEDICOM CO., LTD. makes
IMEDICOM CO., LTD. manufactures single-use surgical saw blades for sagittal and reciprocating applications, as well as orthopaedic osteotome blades. Their portfolio includes power tool attachments for surgical saws, rechargeable battery-powered handpieces, and electric motors for bone/joint procedures. They also provide kits for balloon kyphoplasty and orthopaedic cement preparation and delivery.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. IMEDICOM CO., LTD. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does IMEDICOM CO., LTD. manufacture?
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.
Where is IMEDICOM CO., LTD. based?
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.
Which regulatory registries or databases list IMEDICOM CO., LTD.’s devices?
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.
How are IMEDICOM CO., LTD.’s devices classified under FDA regulations?
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.
What distinguishes IMEDICOM CO., LTD.’s single-use devices from their reusable counterparts?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 690340653
Catalogue (2877)
Page 58 of 58| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| B-Two Inflatable bone expander system syringe | US103002 | FDA UDI | Class II | Active |
| Brasseler EZX | BREZB100 | FDA UDI | Class I | Active |
| Ezx | EZH101 | FDA UDI | Class I | Active |
| Imedicom Saw Blade | BLM-240B | FDA UDI | Class I | Active |
| Imedicom High Speed Blade | NSP-780 | FDA UDI | Class I | Active |
| Brasseler EZX | BR EZX Kit 21 | FDA UDI | Class I | Active |
| Zaguar | BRBDD-100 | FDA UDI | Class I | Active |
| EZX Blade | XTB490 | FDA UDI | Class I | Active |
| Ezx | BRXTL52A | FDA UDI | Class I | Active |
| Imedicom Saw Blade | BMO-470B | FDA UDI | Class I | Active |
| Ezx | XTL58A | FDA UDI | Class I | Active |
| Imedicom Saw Blade | SBL-751A | FDA UDI | Class I | Active |
| Synth™ Plus | SYNTH-SPU28 | FDA UDI | Class II | Active |
| MEDINAUT Plus Kyphoplasty System | MPU2-B2MN2-15 | FDA UDI | Class II | Active |
| Imedicom Saw Blade | KDO-950B | FDA UDI | Class I | Active |
| MEDINAUT Plus Kyphoplasty System | PICD-CA1/ PICD-NDB1 | FDA UDI | Class II | Active |
| Imedicom Saw Blade | BDO-401A | FDA UDI | Class I | Active |
| Ezx | EZX Kit 04 | FDA UDI | Class I | Active |
| EZX Blade | XTB430 | FDA UDI | Class I | Active |
| Imedicom Saw Blade | BSN-260C | FDA UDI | Class I | Active |
| Spinaut-P | K150915 | FDA 510(k) | Class II | Active |
| Epinaut | K173541 | FDA 510(k) | Class II | Active |
| MEDINAUT Kyphoplasty System | K153296 | FDA 510(k) | Class II | Active |
| Spinaut-E, Spinaut-I | K150789 | FDA 510(k) | Class II | Active |
| Medinaut Kyphoplasty System | K133669 | FDA 510(k) | Class II | Active |
| Spinaut-V, Spinaut-S, Spinaut-I | K151268 | FDA 510(k) | Class II | Active |
| MEDINAUT Plus | K182287 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Imedicom Co., Ltd. Gunpo-si Gyeonggi · KR FEI 3009599228