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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K223301
Device Name ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments 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 Number882.4560
Classification Product Code
OLO  
Date Received10/27/2022
Decision Date 07/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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