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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 K083497
Device Name ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
Applicant
ZIMMER, INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Applicant Contact CAROL VIERLING
Correspondent
ZIMMER, INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Correspondent Contact CAROL VIERLING
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/25/2008
Decision Date 02/19/2009
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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