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FDA 510(k)

DynaMatrix/Dynamatrix Plus

K-Number: K161762 · 2017-01-13

ApplicantCook Biotech Incorporated
Decision Date2017-01-13
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DynaMatrix/Dynamatrix Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K161762. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaMatrix/Dynamatrix Plus?

DynaMatrix/Dynamatrix Plus is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K161762.

When did DynaMatrix/Dynamatrix Plus receive FDA 510(k) clearance?

DynaMatrix/Dynamatrix Plus received FDA 510(k) clearance on 2017-01-13, under 510(k) number K161762.

Who is the listed applicant for DynaMatrix/Dynamatrix Plus?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DynaMatrix/Dynamatrix Plus?

The FDA product code for DynaMatrix/Dynamatrix Plus is NPL.

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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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