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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 K083573
Device Name SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact KARL J NITTINGER
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact KARL J NITTINGER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/03/2008
Decision Date 03/04/2009
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
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