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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 K122500
Device Name NEO PS KNEE SYSTEM
Applicant
Pipeline Orthopedics
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact TERRY POWELL
Correspondent
Pipeline Orthopedics
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact TERRY POWELL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/16/2012
Decision Date 05/03/2013
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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