Medical Device Manufacturer · IN , Pune

S.H.Pitkar Orthotools Pvt. , Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2019

Recent clearances: Pitkar Spinal Pedicle Screw System, Pitkar DeftFix System, Pitkar External Fixation System - Rail Mechanism

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - S.H.Pitkar Orthotools Pvt. , Ltd. Orthopedic ✕

5 devices

1-5 of 5

Cleared Sep 09, 2024

Pitkar Spinal Pedicle Screw System

Orthopedic · 224d

Cleared Oct 06, 2020

Pitkar DeftFix System

Orthopedic · 200d

Cleared Jul 29, 2020

Pitkar External Fixation System - Rail Mechanism

Orthopedic · 149d

Cleared Feb 27, 2020

Pitkar Locked Plating System

Orthopedic · 157d

Cleared Oct 16, 2019

Pitkar External Fixation System

Orthopedic · 230d