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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 K181350
Device Name ASTRA-OCT Spine System
Applicant
Spinecraft, LLC
777 Oakmont Ln.
Westmont,  IL  60559
Applicant Contact Ami Akallal-Asaad
Correspondent
Spinecraft, LLC
777 Oakmont Ln.
Westmont,  IL  60559
Correspondent Contact Ami Akallal-Asaad
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received05/22/2018
Decision Date 07/06/2018
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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