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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 the device name listed in this FDA 510(k) record. The listed applicant is Redpoint Medical, LLC. It received FDA 510(k) clearance on 2022-06-09 under 510(k) 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. The listed applicant is Redpoint Medical, LLC. The 510(k) number is K220717.

When did RedPoint Medical's Better Bunion System receive FDA 510(k) clearance?

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

Who is the listed applicant for RedPoint Medical's Better Bunion System?

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

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.

Related Devices (Code: PBF)

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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