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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K130309
Device Name RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
Applicant
Biomet Microfixation
3416 Roxee Run Cove
Bartlett,  TN  38133
Applicant Contact CHRISTINE SCIFERT
Correspondent
Biomet Microfixation
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact CHRISTINE SCIFERT
Regulation Number882.5250
Classification Product Code
GXR  
Date Received02/07/2013
Decision Date 06/17/2013
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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