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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 K113122
Device Name PIPELINE CR PRIMARY KNEE SYSTEM
Applicant
PIPELINE ORTHOPEDICS
901 KING STREET, SUITE 200
ALEXANDRIA,  VA  22314
Applicant Contact TERRY POWELL
Correspondent
PIPELINE ORTHOPEDICS
901 KING STREET, SUITE 200
ALEXANDRIA,  VA  22314
Correspondent Contact TERRY POWELL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/21/2011
Decision Date 03/20/2012
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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