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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
510(k) Number K112802
Device Name PIPELINE TOTAL HIP 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 Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   OQH  
Date Received09/27/2011
Decision Date 03/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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