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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 K050110
Device Name SYNTHES (USA) LCP MODULAR FOOT PLATES
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact KATHY ANDERSON
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact KATHY ANDERSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/18/2005
Decision Date 03/04/2005
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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