EL CAPITAN Anterior Lumbar Interbody Fusion System
K-Number: K214047 · 2022-03-30
ApplicantAstura Medical
Decision Date2022-03-30
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EL CAPITAN Anterior Lumbar Interbody Fusion System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2022-03-30 under approval number K214047. 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 Lumbar Interbody Fusion System?
EL CAPITAN Anterior Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Astura Medical. The 510(k) number is K214047.
When was EL CAPITAN Anterior Lumbar Interbody Fusion System approved by the FDA?
EL CAPITAN Anterior Lumbar Interbody Fusion System received FDA 510(k) clearance on 2022-03-30, under approval number K214047.
What company makes EL CAPITAN Anterior Lumbar Interbody Fusion System?
EL CAPITAN Anterior Lumbar Interbody Fusion System is manufactured by Astura Medical.
What is the FDA product code for EL CAPITAN Anterior Lumbar Interbody Fusion System?
The FDA product code for EL CAPITAN Anterior Lumbar Interbody Fusion 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.