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FDA 510(k)

Adjustable Fixation Device

K-Number: K153186 · 2016-01-28

ApplicantArthrocare Corp.
Decision Date2016-01-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adjustable Fixation Device is a medical device manufactured by Arthrocare Corp.. It received FDA 510(k) clearance on 2016-01-28 under approval number K153186. 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 Adjustable Fixation Device?

Adjustable Fixation Device is a medical device that received FDA 510(k) clearance on 2016-01-28. It is manufactured by Arthrocare Corp.. The 510(k) number is K153186.

When was Adjustable Fixation Device approved by the FDA?

Adjustable Fixation Device received FDA 510(k) clearance on 2016-01-28, under approval number K153186.

What company makes Adjustable Fixation Device?

Adjustable Fixation Device is manufactured by Arthrocare Corp..

What is the FDA product code for Adjustable Fixation Device?

The FDA product code for Adjustable Fixation Device is MBI.

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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.

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