Pitkar Locked Plating System
K-Number: K192619 · 2020-02-27
ApplicantS.H.Pitkar Orthotools Pvt. , Ltd.
Decision Date2020-02-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Pitkar Locked Plating System is a medical device manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-02-27 under approval number K192619. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pitkar Locked Plating System?
Pitkar Locked Plating System is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K192619.
When was Pitkar Locked Plating System approved by the FDA?
Pitkar Locked Plating System received FDA 510(k) clearance on 2020-02-27, under approval number K192619.
What company makes Pitkar Locked Plating System?
Pitkar Locked Plating System is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd..
What is the FDA product code for Pitkar Locked Plating System?
The FDA product code for Pitkar Locked Plating System is HRS.
Related Clinical Trials
Other Devices by S.H.Pitkar Orthotools Pvt. , Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.