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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 K214047
Device Name EL CAPITAN Anterior Lumbar Interbody Fusion System
Applicant
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Applicant Contact Parker Kelch
Correspondent
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Correspondent Contact Parker Kelch
Regulation Number888.3080
Classification Product Code
OVD  
Date Received12/27/2021
Decision Date 03/30/2022
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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