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FDA 510(k)

FootHold System

K-Number: K220797 · 2022-04-15

ApplicantCrossroads Extremity Systems, LLC
Decision Date2022-04-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FootHold System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220797. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FootHold System?

FootHold System is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K220797.

When did FootHold System receive FDA 510(k) clearance?

FootHold System received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220797.

Who is the listed applicant for FootHold System?

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

What is the FDA product code for FootHold System?

The FDA product code for FootHold System is MBI.

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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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