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Sign in to claim this brandSolco Biomedical Copany India Private Limited
US
Last updated May 23, 2026
What Solco Biomedical Copany India Private Limited makes
Solco Biomedical Company India Private Limited manufactures spinal fixation systems, including modular screw and rod assemblies like the 4CIS SARA and VERTU spine systems, as well as the aBle and aBle Xt spinal fixation solutions. These products are designed for surgical stabilization of the spine, incorporating pedicle screws and other hardware for internal fixation.
The company’s devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) clearance registry. The manufacturer operates from the United States, adhering to applicable medical device regulations for spinal implants.
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 Solco Biomedical Company India Private Limited manufacture?
Solco Biomedical Company India Private Limited specializes in spinal fixation systems. These include modular screw and rod assemblies such as the 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, and the aBle SPINAL FIXATION SYSTEM. The company’s products are designed for surgical stabilization of the spine, often involving pedicle screws and other hardware to provide internal fixation. These devices are intended for use in procedures requiring controlled alignment and support of the spine.
Where is Solco Biomedical Company India Private Limited based, and how does this affect its regulatory compliance?
Solco Biomedical Company India Private Limited is based in the United States. As a U.S.-based manufacturer, the company must comply with the regulatory requirements of the FDA, including the classification and clearance processes for its medical devices. The U.S. regulatory framework ensures that devices like spinal fixation systems meet safety, performance, and efficacy standards before they are authorized for market distribution.
Which regulatory registries list Solco Biomedical Company India Private Limited’s devices?
Solco Biomedical Company India Private Limited’s devices are listed in the FDA’s 510(k) clearance registry. The 510(k) process is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulations before clearance. This registry provides transparency on the authorized devices and their regulatory status.
How are Solco Biomedical Company India Private Limited’s spinal fixation systems classified under regulatory frameworks?
Solco Biomedical Company India Private Limited’s spinal fixation systems are classified as Class II devices. This classification is determined based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. The classification helps regulators and healthcare providers understand the regulatory scrutiny applied to these products.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (677)
Page 1 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 4cis Vertu Spine System | AISP-2806-7010 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1010-0004 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2806-7545 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1506-5507 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1035-7570 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1016-6585 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1016-7060 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2805-7550 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1036-7540 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2801-6565 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2805-7595 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2806-7555 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1036-7570 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1016-6595 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1016-7545 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1016-7035 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2802-7045 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2802-7070 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1035-7070 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2803-6585 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1507-5530 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1036-7580 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1507-5505 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2804-7595 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2803-7090 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2805-7070 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2801-7090 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1703-3846 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2803-6575 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2807-6510 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1012-6570 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1035-7540 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2806-7570 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1036-6580 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2802-7595 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1035-6565 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1012-7060 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1506-5550 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2802-6560 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1038-7555 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1036-6570 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2806-6590 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2808-6590 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1038-6535 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1507-5514 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-1035-7555 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-2802-6540 | FDA UDI | Class II | Active |
| 4cis Vertu Spine System | AISP-2807-7575 | FDA UDI | Class II | Active |
| 4cis Sara/Vertu Spine System | AISP-1519-5508 | FDA UDI | Class II | Active |
| 4cis Sara Spine System | AISP-1020-6555 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Solco Biomedical Company India Private Limited KADI Gujarat · IN FEI 3016443334