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FDA 510(k)

CalcShift™ Displacement Calcaneal Osteotomy System

K-Number: K212979 · 2022-05-20

ApplicantNextremity Solutions, Inc.
Decision Date2022-05-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CalcShift™ Displacement Calcaneal Osteotomy System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2022-05-20 under approval number K212979. 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 CalcShift™ Displacement Calcaneal Osteotomy System?

CalcShift™ Displacement Calcaneal Osteotomy System is a medical device that received FDA 510(k) clearance on 2022-05-20. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K212979.

When was CalcShift™ Displacement Calcaneal Osteotomy System approved by the FDA?

CalcShift™ Displacement Calcaneal Osteotomy System received FDA 510(k) clearance on 2022-05-20, under approval number K212979.

What company makes CalcShift™ Displacement Calcaneal Osteotomy System?

CalcShift™ Displacement Calcaneal Osteotomy System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for CalcShift™ Displacement Calcaneal Osteotomy System?

The FDA product code for CalcShift™ Displacement Calcaneal Osteotomy System is HRS.

Related Clinical Trials

NCT05966519 ROSA Knee Intraoperative Planning Flexibility Study RECRUITING

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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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