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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K090984
Device Name INERTIA PEDICLE SCREW SYSTEM
Applicant
Nexxt Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Applicant Contact KAREN WARDEN
Correspondent
Nexxt Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Correspondent Contact KAREN WARDEN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received04/07/2009
Decision Date 06/30/2009
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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