Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-01-13 under approval 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. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K161762.

When was DynaMatrix/Dynamatrix Plus approved by the FDA?

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

What company makes DynaMatrix/Dynamatrix Plus?

DynaMatrix/Dynamatrix Plus is manufactured by Cook Biotech Incorporated.

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

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

Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft

View all 13 devices →

Related Devices (Code: NPL)

K160281OSSIX PLUSDatum Dental, Ltd. K153549OSSIX VOLUMAXDatum Dental, Ltd. K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical K171050Geistlich Fibro-GideGeistlich Pharma AG K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG K173562Straumann Jason MembraneInstitut Straumann AG

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.

↑