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FDA 510(k)

RESTORE BUNION CORRECTION SYSTEM

K-Number: K131061 · 2013-08-28

ApplicantNextremity Solutions
Decision Date2013-08-28
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESTORE BUNION CORRECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K131061. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORE BUNION CORRECTION SYSTEM?

RESTORE BUNION CORRECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Nextremity Solutions. The 510(k) number is K131061.

When did RESTORE BUNION CORRECTION SYSTEM receive FDA 510(k) clearance?

RESTORE BUNION CORRECTION SYSTEM received FDA 510(k) clearance on 2013-08-28, under 510(k) number K131061.

Who is the listed applicant for RESTORE BUNION CORRECTION SYSTEM?

The FDA 510(k) record lists Nextremity Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTORE BUNION CORRECTION SYSTEM?

The FDA product code for RESTORE BUNION CORRECTION SYSTEM is JDR.

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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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