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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K964163
Device Name TRIMAX NAIL SYSTEM
Applicant
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/17/1996
Decision Date 12/27/1996
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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