FDA 510(k)

Fixated Asfora BULLET CAGE® (FABC)

K-Number: K181591 · 2018-09-26

Decision Date2018-09-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fixated Asfora BULLET CAGE® (FABC) is a medical device manufactured by Medical Designs, LLC. It received FDA 510(k) clearance on 2018-09-26 under approval number K181591. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fixated Asfora BULLET CAGE® (FABC)?

Fixated Asfora BULLET CAGE® (FABC) is a medical device that received FDA 510(k) clearance on 2018-09-26. It is manufactured by Medical Designs, LLC. The 510(k) number is K181591.

When was Fixated Asfora BULLET CAGE® (FABC) approved by the FDA?

Fixated Asfora BULLET CAGE® (FABC) received FDA 510(k) clearance on 2018-09-26, under approval number K181591.

What company makes Fixated Asfora BULLET CAGE® (FABC)?

Fixated Asfora BULLET CAGE® (FABC) is manufactured by Medical Designs, LLC.

What is the FDA product code for Fixated Asfora BULLET CAGE® (FABC)?

The FDA product code for Fixated Asfora BULLET CAGE® (FABC) is MAX.

Other Devices by Medical Designs, LLC

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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.