Clearance Summary
Pitkar External Fixation System - Rail Mechanism received FDA 510(k) clearance under submission number K200518, sponsored by S.H.Pitkar Orthotools Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-07-29.
- Submission: K200518
- Applicant / Sponsor: S.H.Pitkar Orthotools Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2020-07-29
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.