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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, threaded
510(k) Number K120871
Device Name SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact GINO ROUSS
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact GINO ROUSS
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Codes
KTT   LXT   OSN  
Date Received03/22/2012
Decision Date 06/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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