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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 K003797
Device Name ACE AIM TTC FUSION NAIL
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact MARCIA J ARENTZ
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact MARCIA J ARENTZ
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/08/2000
Decision Date 12/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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