The following data is part of a premarket notification filed by S H Pitkar Orthotools Pvt Ltd with the FDA for Pitkar External Fixation System - Rail Mechanism.
| Device ID | K200518 |
| 510k Number | K200518 |
| Device Name: | Pitkar External Fixation System - Rail Mechanism |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | S H Pitkar Orthotools Pvt Ltd Plot No. EL 32, J Block, MIDC Bhosari Pune, IN 411026 |
| Contact | Vivek Mangalwedhekar |
| Correspondent | Vivek Mangalwedhekar S H Pitkar Orthotools Pvt Ltd Plot No. EL 32, J Block, MIDC Bhosari Pune, IN 411026 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-07-29 |