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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 K190355
Device Name Precision Casting Solutions Total Knee System
Applicant
Precision Casting Solutions, Inc.
20031 Henrici Rd.
Oregon City,  OR  97045
Applicant Contact Jim Moore
Correspondent
Precision Casting Solutions, Inc.
20031 Henrici Rd.
Oregon City,  OR  97045
Correspondent Contact Jim Moore
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/15/2019
Decision Date 05/16/2019
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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