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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 K133475
Device Name STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
Applicant
Nexxt Spine, LLC
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Applicant Contact ERIC LINTULA
Correspondent
Nexxt Spine, LLC
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Correspondent Contact ERIC LINTULA
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/12/2013
Decision Date 12/19/2013
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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