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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 a medical device manufactured by Hyperflex Medical. It received FDA 510(k) clearance on 2025-12-11 under approval 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. It is manufactured by Hyperflex Medical. The 510(k) number is K252997.

When was HyperFlex® Bunion Correction System approved by the FDA?

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

What company makes HyperFlex® Bunion Correction System?

HyperFlex® Bunion Correction System is manufactured by Hyperflex Medical.

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

The FDA product code for HyperFlex® Bunion Correction System is 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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