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FDA 510(k)

IRENE Locking Compression Plate System

K-Number: K151508 · 2016-02-25

ApplicantTianjin Zhengtian Medical Instrument Co., Ltd.
Decision Date2016-02-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRENE Locking Compression Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151508. 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 IRENE Locking Compression Plate System?

IRENE Locking Compression Plate System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K151508.

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

IRENE Locking Compression Plate System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151508.

Who is the listed applicant for IRENE Locking Compression Plate System?

The FDA 510(k) record lists Tianjin Zhengtian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRENE Locking Compression Plate System?

The FDA product code for IRENE Locking Compression Plate System is HRS.

Other records listing Tianjin Zhengtian Medical Instrument 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.

K172267IRENE Thoracolumbar Fixation SystemK170056IRENE Cannulated Screw System

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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