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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K131417
Device Name FACET FIXX
Applicant
Nexxt Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN PHD
Correspondent
Nexxt Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN PHD
Classification Product Code
MRW  
Date Received05/16/2013
Decision Date 07/12/2013
Decision Substantially Equivalent (SESE)
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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