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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K151424
Device Name The Progressive Orthopaedic Total Hip System
Applicant
The Progressive Orthopaedic Company, LLC
801 Us Highway 1, Suite B
North Palm Beach,  FL  33408
Applicant Contact Scott Keiser
Correspondent
The Progressive Orthopaedic Company, LLC
801 Us Highway 1, Suite B
North Palm Beach,  FL  33408
Correspondent Contact Thomas Smith
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received05/28/2015
Decision Date 07/27/2016
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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