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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 the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2022-05-20 under 510(k) 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. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K212979.

When did CalcShift™ Displacement Calcaneal Osteotomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for CalcShift™ Displacement Calcaneal Osteotomy System?

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

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

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

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Related Devices (Code: HRS)

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

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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