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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 K063049
Device Name SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact DEBORAH L JACKSON
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact DEBORAH L JACKSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/04/2006
Decision Date 12/18/2006
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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