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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K091110
Device Name SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
Applicant
Spinal Edge, LLC
33650 Reserve Way
Avon,  OH  44011
Applicant Contact CHRISTINA VACCA
Correspondent
Spinal Edge, LLC
33650 Reserve Way
Avon,  OH  44011
Correspondent Contact CHRISTINA VACCA
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received04/17/2009
Decision Date 07/24/2009
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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