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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 K092531
Device Name SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
Applicant
SPINE 360
5000 PLAZA ON THE LAKE
SUITE 305
AUSTIN,  TX  78746
Applicant Contact JOSHUA KAUFMANN
Correspondent
SPINE 360
5000 PLAZA ON THE LAKE
SUITE 305
AUSTIN,  TX  78746
Correspondent Contact JOSHUA KAUFMANN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/18/2009
Decision Date 02/04/2010
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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