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FDA 510(k)

HyperFlex™ Bunion Correction System

K-Number: K241995 · 2024-11-26

ApplicantFootbridge Medical
Decision Date2024-11-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HyperFlex™ Bunion Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Footbridge Medical. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K241995. 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 HyperFlex™ Bunion Correction System?

HyperFlex™ Bunion Correction System is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Footbridge Medical. The 510(k) number is K241995.

When did HyperFlex™ Bunion Correction System receive FDA 510(k) clearance?

HyperFlex™ Bunion Correction System received FDA 510(k) clearance on 2024-11-26, under 510(k) number K241995.

Who is the listed applicant for HyperFlex™ Bunion Correction System?

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

What is the FDA product code for HyperFlex™ Bunion Correction System?

The FDA product code for HyperFlex™ Bunion Correction System 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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