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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 K122783
Device Name PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
Original Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact julie tom wing
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LWJ   LZO   OQH  
OQI  
Date Received09/11/2012
Decision Date 10/30/2013
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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