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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-02-27 under 510(k) 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. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K192619.

When did Pitkar Locked Plating System receive FDA 510(k) clearance?

Pitkar Locked Plating System received FDA 510(k) clearance on 2020-02-27, under 510(k) number K192619.

Who is the listed applicant for Pitkar Locked Plating System?

The FDA 510(k) record lists S.H.Pitkar Orthotools Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pitkar Locked Plating System?

The FDA product code for Pitkar Locked Plating System is HRS.

Other records listing S.H.Pitkar Orthotools Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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