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FDA 510(k)

Locking Plates and Screws Systems

K-Number: K240958 · 2025-02-10

ApplicantHebei Ruihe Medical Devices Co., Ltd.
Decision Date2025-02-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Locking Plates and Screws Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Ruihe Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K240958. 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 Locking Plates and Screws Systems?

Locking Plates and Screws Systems is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Hebei Ruihe Medical Devices Co., Ltd.. The 510(k) number is K240958.

When did Locking Plates and Screws Systems receive FDA 510(k) clearance?

Locking Plates and Screws Systems received FDA 510(k) clearance on 2025-02-10, under 510(k) number K240958.

Who is the listed applicant for Locking Plates and Screws Systems?

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

What is the FDA product code for Locking Plates and Screws Systems?

The FDA product code for Locking Plates and Screws Systems is HRS.

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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