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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
510(k) Number K122382
Device Name DYNASTY BIOFOAM SHELL
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact dean nachtrab
Regulation Number888.3358
Classification Product Code
MBL  
Subsequent Product Codes
JDI   LZO  
Date Received08/06/2012
Decision Date 10/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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