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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K133091
Device Name ZIP MIS INTERSPINOUS FUSION SYSTEM
Applicant
Aurora Spine
331 H St. NW, 12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Aurora Spine
331 H St. NW, 12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3050
Classification Product Code
PEK  
Date Received09/30/2013
Decision Date 11/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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