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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 K011857
Device Name SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received06/14/2001
Decision Date 09/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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