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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 K240690
Device Name STRUXXURE® MCS Anterior Cervical Plate System
Applicant
Nexxt Spine
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Applicant Contact Andy Elsbury
Correspondent
Cecka Consulting Group
163 Alvarado Rd.
Berkeley,  CA  94705
Correspondent Contact Jeannie Cecka
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/13/2024
Decision Date 03/22/2024
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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