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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K072758
Device Name SYNTHES (USA) 2.0MM TITANIUM T-PLATE
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact ANDREA M TASKER
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact ANDREA M TASKER
Regulation Number882.5320
Classification Product Code
GWO  
Date Received09/28/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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