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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K191765
Device Name OMNI TiN Coated Apex Knee™ System
Applicant
Omni Life Science, Inc.
480 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Christina Rovaldi
Correspondent
Omni Life Science, Inc.
480 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Christina Rovaldi
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/01/2019
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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