EL CAPITAN Anterior Lumber Interbody System
K-Number: K192492 · 2020-04-21
ApplicantAstura Medical, LLC
Decision Date2020-04-21
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EL CAPITAN Anterior Lumber Interbody System is a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2020-04-21 under approval number K192492. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EL CAPITAN Anterior Lumber Interbody System?
EL CAPITAN Anterior Lumber Interbody System is a medical device that received FDA 510(k) clearance on 2020-04-21. It is manufactured by Astura Medical, LLC. The 510(k) number is K192492.
When was EL CAPITAN Anterior Lumber Interbody System approved by the FDA?
EL CAPITAN Anterior Lumber Interbody System received FDA 510(k) clearance on 2020-04-21, under approval number K192492.
What company makes EL CAPITAN Anterior Lumber Interbody System?
EL CAPITAN Anterior Lumber Interbody System is manufactured by Astura Medical, LLC.
What is the FDA product code for EL CAPITAN Anterior Lumber Interbody System?
The FDA product code for EL CAPITAN Anterior Lumber Interbody System is OVD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.