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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 K111065
Model 5444-0-X00 WHERE X RANGES BETWEEN 1 AND 5
Device Name STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
Original Applicant
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS
325 corporate drive
mahwah,  NJ  07430
Original Contact caludia wiesemann
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
KKY  
Date Received04/19/2011
Decision Date 07/14/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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