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FDA 510(k)

Gaudi Proximal Humerus Plate

K-Number: K241296 · 2024-07-23

ApplicantNetbiologics, LLC
Decision Date2024-07-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gaudi Proximal Humerus Plate is the device name listed in this FDA 510(k) record. The listed applicant is Netbiologics, LLC. It received FDA 510(k) clearance on 2024-07-23 under 510(k) number K241296. 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 Gaudi Proximal Humerus Plate?

Gaudi Proximal Humerus Plate is a medical device that received FDA 510(k) clearance on 2024-07-23. The listed applicant is Netbiologics, LLC. The 510(k) number is K241296.

When did Gaudi Proximal Humerus Plate receive FDA 510(k) clearance?

Gaudi Proximal Humerus Plate received FDA 510(k) clearance on 2024-07-23, under 510(k) number K241296.

Who is the listed applicant for Gaudi Proximal Humerus Plate?

The FDA 510(k) record lists Netbiologics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gaudi Proximal Humerus Plate?

The FDA product code for Gaudi Proximal Humerus Plate 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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