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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 K150783
Device Name Progressive Orthopaedic Total Knee System
Applicant
The Progressive Orthopaedic Company, LLC
801 Us Hwy. 1, Suite B
North Palm Beach,  FL  33408
Applicant Contact Scott Keiser
Correspondent
The Progressive Orthopaedic Company, LLC
801 Us Hwy. 1, Suite B
North Palm Beach,  FL  33408
Correspondent Contact Thomas Smith
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/25/2015
Decision Date 06/23/2015
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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