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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, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K140676
Device Name PROFEMUR TL CLASSIC LONG NECK HIP STEMS
Applicant
MICROPORT ORTHOPEDICS INC.
5677 AIRLINE RD
ARLINGTON,  TN  38002
Applicant Contact BYRON LEDBETTER
Correspondent
MICROPORT ORTHOPEDICS INC.
5677 AIRLINE RD
ARLINGTON,  TN  38002
Correspondent Contact BYRON LEDBETTER
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   MBL  
Date Received03/18/2014
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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