510(k) K200518
K200518 is an FDA 510(k) premarket notification submitted by S.H.Pitkar Orthotools Pvt. , Ltd. for the device "Pitkar External Fixation System - Rail Mechanism". The FDA issued a decision of Substantially Equivalent on July 29, 2020. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. S.H.Pitkar Orthotools Pvt. , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2020
- Date Received
- March 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type