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FDA 510(k)

Ortho Solutions Plating System

K-Number: K202764 · 2020-11-20

ApplicantOrtho Solutions UK , Ltd.
Decision Date2020-11-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ortho Solutions Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK , Ltd.. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K202764. 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 Ortho Solutions Plating System?

Ortho Solutions Plating System is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Ortho Solutions UK , Ltd.. The 510(k) number is K202764.

When did Ortho Solutions Plating System receive FDA 510(k) clearance?

Ortho Solutions Plating System received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202764.

Who is the listed applicant for Ortho Solutions Plating System?

The FDA 510(k) record lists Ortho Solutions UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ortho Solutions Plating System?

The FDA product code for Ortho Solutions Plating System is HRS.

Other records listing Ortho Solutions UK , 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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