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FDA 510(k)

Tandry Locking Plate System

K-Number: K171904 · 2018-09-18

ApplicantMicroware Precision Co., Ltd.
Decision Date2018-09-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tandry Locking Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K171904. 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 Tandry Locking Plate System?

Tandry Locking Plate System is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K171904.

When did Tandry Locking Plate System receive FDA 510(k) clearance?

Tandry Locking Plate System received FDA 510(k) clearance on 2018-09-18, under 510(k) number K171904.

Who is the listed applicant for Tandry Locking Plate System?

The FDA 510(k) record lists Microware Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tandry Locking Plate System?

The FDA product code for Tandry Locking Plate System is HRS.

Other records listing Microware Precision Co., 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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