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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 K192492
Device Name EL CAPITAN Anterior Lumber Interbody 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 Number888.3080
Classification Product Code
OVD  
Date Received09/11/2019
Decision Date 04/21/2020
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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