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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 intervertebral body
510(k) Number K122733
Device Name V2F ANTERIOR FIXATION SYSTEM
Applicant
ZIMMER SPINE, INC
5301 RIATA PARK COURT
BUILDING F
AUSTIN,  TX  78727
Applicant Contact JENNIFER TRIBBETT
Correspondent
ZIMMER SPINE, INC
5301 RIATA PARK COURT
BUILDING F
AUSTIN,  TX  78727
Correspondent Contact JENNIFER TRIBBETT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/06/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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