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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 the device name listed in this FDA 510(k) record. The listed applicant is Coracoid Solutions, Inc.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) 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. The listed applicant is Coracoid Solutions, Inc.. The 510(k) number is K153211.

When did M-Fix Acromioclavicular Device receive FDA 510(k) clearance?

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

Who is the listed applicant for M-Fix Acromioclavicular Device?

The FDA 510(k) record lists Coracoid Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: HTN)

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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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