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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K133556
Device Name VIRAGE OCT SPINAL FIXATION SYSTEM
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Applicant Contact HOLLY SEPPANEN
Correspondent
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Correspondent Contact HOLLY SEPPANEN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/19/2013
Decision Date 06/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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