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FDA 510(k)

HyperFlex® Bunion Correction System

K-Number: K252997 · 2025-12-11

ApplicantHyperflex Medical
Decision Date2025-12-11
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 Hyperflex Medical. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252997. 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 2025-12-11. The listed applicant is Hyperflex Medical. The 510(k) number is K252997.

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

HyperFlex® Bunion Correction System received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252997.

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

The FDA 510(k) record lists Hyperflex 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.

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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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