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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K180249
Device Name OmniPore DUROMAX Surgical Implants
Applicant
Matrix Surgical Holdings, LLC/Matrix Surgical USA
4025 Welcome All Rd.
Suite 120
Atlanta,  GA  30349
Applicant Contact John O'Shaughnessy
Correspondent
Regulatory Resources Group, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact Julie Stephens
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/29/2018
Decision Date 10/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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