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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 K122158
Device Name PBP TOTAL HIP SYSTEM
Original Applicant
PIPELINE BIOMEDICAL PRODUCTS, LLC
901 king street
suite 200
alexandria,  VA  22314
Original Contact terry powell
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LZO   MEH   OQH  
OQI  
Date Received07/20/2012
Decision Date 12/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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