Rail Fixation System
- UID
- MFG/MD/2023/000085_3a01486ea8bb3e5f4bbf95d3e9c03e62_b6ef9a640dd18b5e75ca59177c543bd9
- Device class
- Class B
- Brand name
- Pitkar
- License holder
- S.H.Pitkar Orthotools Pvt. Ltd.
- Approving authority
- Pune Division
- Product information
- External Fixation System- Rail fixator components are intended to be used on adult or pediatric patients as required.As a general rule it is better to avoid operating on children under the age of five. In the children above age 10, the rail 300 mm may be more appropriate. The pediatric system is designed for use in children under the age of 10
Rail Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000085_3a01486ea8bb3e5f4bbf95d3e9c03e62_b6ef9a640dd18b5e75ca59177c543bd9. This device is marketed under the brand name Pitkar. The license holder is S.H.Pitkar Orthotools Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Pune Division.
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