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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 K141123
Device Name ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
Applicant
ALLIANCE PARTNERS, LLC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Applicant Contact TIM LOHNES
Correspondent
ALLIANCE PARTNERS, LLC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Correspondent Contact TIM LOHNES
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received05/01/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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