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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K211323
Device Name ASTRA Spine System
Applicant
Spinecraft, LLC
777 Oakmont Ln., Suite 200
Westmont,  IL  60559
Applicant Contact Ami Akallal-Asaad
Correspondent
Spinecraft, LLC
777 Oakmont Ln., Suite 200
Westmont,  IL  60559
Correspondent Contact Ami Akallal-Asaad
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received04/30/2021
Decision Date 06/03/2021
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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