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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/Polymer, Cemented
510(k) Number K970351
Device Name GLOBAL TAPER SPECTRON HIP STEMS
Applicant
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LWJ  
Date Received01/30/1997
Decision Date 02/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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