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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, Non-Alterable
510(k) Number K052871
Device Name STRYKER CUSTOM TI IMPLANT
Applicant
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact WADE T RUTKOSKIE
Correspondent
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact WADE T RUTKOSKIE
Regulation Number882.5330
Classification Product Code
GXN  
Date Received10/11/2005
Decision Date 12/16/2005
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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