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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K091479
Device Name APTUS FOOT SYSTEM
Applicant
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA SCHULZ
Correspondent
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA SCHULZ
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/19/2009
Decision Date 07/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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