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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K191185
Device Name Solanas® Posterior OCT Fixation System
Applicant
Alphatec Spine
5818 El Camino Real
Carlsnad,  CA  92008
Applicant Contact Ruby Zheng
Correspondent
Alphatec Spine
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact Ruby Zheng
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received05/03/2019
Decision Date 06/03/2019
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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