S.H.Pitkar Orthotools Pvt., Ltd.
IndiaFDA 510(k) applicant, unverified
- Devices
- 5
What S.H.Pitkar Orthotools Pvt., Ltd. makes
The company designs and manufactures orthopedic fixation systems, including external fixation devices for bone stabilization, modular rail mechanisms for adjustable fixation, locked plating systems for internal bone support, and spinal pedicle screw systems for vertebral stabilization.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Pitkar External Fixation System Ref K190486
510(k) 510(k)Pitkar DeftFix System Ref K200728
510(k) 510(k)Pitkar External Fixation System - Rail Mechanism Ref K200518
510(k) 510(k)Pitkar Locked Plating System Ref K192619
510(k) 510(k)Pitkar Spinal Pedicle Screw System Ref K240233
510(k) 510(k)
Frequently asked questions
How many devices does S.H.Pitkar Orthotools Pvt., Ltd. have in the registry?
The registry currently lists 5 devices for S.H.Pitkar Orthotools Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list S.H.Pitkar Orthotools Pvt., Ltd.'s devices?
Among its 5 most recently registered devices, S.H.Pitkar Orthotools Pvt., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do S.H.Pitkar Orthotools Pvt., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for S.H.Pitkar Orthotools Pvt., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from S.H.Pitkar Orthotools Pvt., Ltd. in the registry?
The most recently registered devices listed for S.H.Pitkar Orthotools Pvt., Ltd. include Pitkar External Fixation System, Pitkar DeftFix System, Pitkar External Fixation System - Rail Mechanism and Pitkar Locked Plating System.