Rail Fixation System - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Rail Fixation System

UID: MFG/MD/2023/000085_3a01486ea8bb3e5f4bbf95d3e9c03e62_b6ef9a640dd18b5e75ca59177c543bd9

Brand Name

Pitkar

License Holder

S.H.Pitkar Orthotools Pvt. Ltd.

Device Class

Class B

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