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 a medical device manufactured by Footbridge Medical. It received FDA 510(k) clearance on 2024-11-26 under approval 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. It is manufactured by Footbridge Medical. The 510(k) number is K241995.
When was HyperFlex Bunion Correction System approved by the FDA?
HyperFlex Bunion Correction System received FDA 510(k) clearance on 2024-11-26, under approval number K241995.
What company makes HyperFlex Bunion Correction System?
HyperFlex Bunion Correction System is manufactured by Footbridge 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.