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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
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact DEAN NACHTRAB
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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