Computer Assisted Surgery System
- UID
- IMP/MD/2023/000564_f0e80aefd7be6dc148e3941c7bd87882_ae6f2caf14a1c04d721e9cc2bc43318a
- Device class
- Class C
- Brand name
- ROSA One System
- License holder
- Zimmer India Private Limited
- Approving authority
- CDSCO
- Product information
- The ROSA One is intended to be used for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during brain and spine surgeries. For the Brain application, the device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (ROSA One System). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Computer Assisted Surgery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000564_f0e80aefd7be6dc148e3941c7bd87882_ae6f2caf14a1c04d721e9cc2bc43318a. This device is marketed under the brand name ROSA One System. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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