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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K190426
Device Name ALTA Anterior Cervical Corpectomy System
Applicant
Astura Medical, LLC
3186 Lionshead Ave, Suite 100
Carlsbad,  CA  92010
Applicant Contact Parker Kelch
Correspondent
Astura Medical, LLC
3186 Lionshead Ave, Suite 100
Carlsbad,  CA  92010
Correspondent Contact Parker Kelch
Regulation Number888.3060
Classification Product Code
PLR  
Date Received02/22/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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