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FDA 510(k)

RedPoint Medical's Better Bunion System

K-Number: K220717 · 2022-06-09

ApplicantRedpoint Medical, LLC
Decision Date2022-06-09
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RedPoint Medical's Better Bunion System is a medical device manufactured by Redpoint Medical, LLC. It received FDA 510(k) clearance on 2022-06-09 under approval number K220717. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RedPoint Medical's Better Bunion System?

RedPoint Medical's Better Bunion System is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by Redpoint Medical, LLC. The 510(k) number is K220717.

When was RedPoint Medical's Better Bunion System approved by the FDA?

RedPoint Medical's Better Bunion System received FDA 510(k) clearance on 2022-06-09, under approval number K220717.

What company makes RedPoint Medical's Better Bunion System?

RedPoint Medical's Better Bunion System is manufactured by Redpoint Medical, LLC.

What is the FDA product code for RedPoint Medical's Better Bunion System?

The FDA product code for RedPoint Medical's Better Bunion System is PBF.

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Related PubMed Literature

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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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