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Product availability, approved indications and certain content on this website vary by country.

Safety information

Patient information

Robotic surgery is a type of procedure in which a surgeon uses a robotic system to operate on qualified patients. The surgeon controls the system at all times.

Not every patient is a candidate for robotic surgery. Patient selection is based on anatomy, physical and physiological characteristics and medical history, in consultation with the patient's physician. SS Innovations is not involved in patient selection.

Complications can occur in any surgery, including robotic surgery. They may include, but are not limited to, injury to tissues and organs, conversion to laparoscopic or open surgery, and death. Patients should consult their doctors and understand the risks and benefits associated with robotic surgery.

Information for surgeons

The SSi Mantra Surgical Robotic System is intended for use by qualified physicians in an operating room environment. It should be used only by surgeons trained and qualified by SS Innovations. Training provided by SS Innovations is limited to the use of the SSi Mantra system and does not replace the medical training and experience required to perform surgery.

For indications for use, contraindications, warnings and precautions, refer to the SSi Mantra user manual.

Regulatory status

SSi Mantra is approved for commercial use in India by the Central Drugs Standard Control Organisation (CDSCO). Product availability and approved indications are subject to regulatory clearance or approval in each jurisdiction, and products may not be available in all countries or regions. SSi Mantra has not been cleared by the U.S. Food and Drug Administration (FDA) and does not bear the CE mark; it is not available for sale in the United States or the European Union.

Use of this website

Clinical and procedural information on this website relates to the use of SSi Mantra in jurisdictions in which it has received regulatory approval. Such information is provided for general informational purposes only. It does not constitute an offer for sale, or a promotion of any product or indication, in any jurisdiction in which the product has not been cleared or approved, and it is not a substitute for professional medical judgement, the product labelling or the instructions for use.

Quality management

Sudhir Srivastava Innovations Pvt. Ltd. (research and development headquarters, India) and the SSi Mantra Surgical Robotic System are certified to EN ISO 13485:2016. CDSCO Manufacturing Licence No. MFG/MD/2024/000827.

Product disclaimer

Product images on this website are for illustrative purposes only. Actual products may differ as a result of product enhancements.