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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 a medical device manufactured by Netbiologics, LLC. It received FDA 510(k) clearance on 2024-07-23 under approval 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. It is manufactured by Netbiologics, LLC. The 510(k) number is K241296.

When was Gaudi Proximal Humerus Plate approved by the FDA?

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

What company makes Gaudi Proximal Humerus Plate?

Gaudi Proximal Humerus Plate is manufactured by Netbiologics, LLC.

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

The FDA product code for Gaudi Proximal Humerus Plate is HRS.

Related Clinical Trials

NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

Related Devices (Code: HRS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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