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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 K141376
Device Name INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
Applicant
Nexxt Spine, LLC
P.O. Box 566
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
Nexxt Spine, LLC
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MAX   MNI   MQP  
MRW   ODP  
Date Received05/27/2014
Decision Date 06/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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