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FDA 510(k)

M-Fix Acromioclavicular Device

K-Number: K153211 · 2016-02-02

ApplicantCoracoid Solutions, Inc.
Decision Date2016-02-02
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-Fix Acromioclavicular Device is a medical device manufactured by Coracoid Solutions, Inc.. It received FDA 510(k) clearance on 2016-02-02 under approval number K153211. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-Fix Acromioclavicular Device?

M-Fix Acromioclavicular Device is a medical device that received FDA 510(k) clearance on 2016-02-02. It is manufactured by Coracoid Solutions, Inc.. The 510(k) number is K153211.

When was M-Fix Acromioclavicular Device approved by the FDA?

M-Fix Acromioclavicular Device received FDA 510(k) clearance on 2016-02-02, under approval number K153211.

What company makes M-Fix Acromioclavicular Device?

M-Fix Acromioclavicular Device is manufactured by Coracoid Solutions, Inc..

What is the FDA product code for M-Fix Acromioclavicular Device?

The FDA product code for M-Fix Acromioclavicular Device is HTN.

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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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