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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K222554
Device Name EL CAPITAN Anterior Lumbar Interbody Fusion
Astura Medical
4949 W Royal Ln.
Irving,  TX  75063
Applicant Contact Parker Kelch
Astura Medical
4949 W Royal Ln.
Irving,  TX  75063
Correspondent Contact Parker Kelch
Regulation Number888.3080
Classification Product Code
Date Received08/23/2022
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No