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FDA 510(k)

Fixated Asfora BULLET CAGE® (FABC)

K-Number: K181591 · 2018-09-26

ApplicantMedical Designs, LLC
Decision Date2018-09-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixated Asfora BULLET CAGE® (FABC) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Designs, LLC. It received FDA 510(k) clearance on 2018-09-26 under 510(k) 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. The listed applicant is Medical Designs, LLC. The 510(k) number is K181591.

When did Fixated Asfora BULLET CAGE® (FABC) receive FDA 510(k) clearance?

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

Who is the listed applicant for Fixated Asfora BULLET CAGE® (FABC)?

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

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 records listing Medical Designs, LLC as applicant

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.

K182352SP-LINK™ System

Related Devices (Code: MAX)

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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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