EL CAPITAN Anterior Lumbar Interbody Fusion
K-Number: K222554 · 2023-01-19
ApplicantAstura Medical
Decision Date2023-01-19
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EL CAPITAN Anterior Lumbar Interbody Fusion is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2023-01-19 under approval number K222554. 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?
EL CAPITAN Anterior Lumbar Interbody Fusion is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Astura Medical. The 510(k) number is K222554.
When was EL CAPITAN Anterior Lumbar Interbody Fusion approved by the FDA?
EL CAPITAN Anterior Lumbar Interbody Fusion received FDA 510(k) clearance on 2023-01-19, under approval number K222554.
What company makes EL CAPITAN Anterior Lumbar Interbody Fusion?
EL CAPITAN Anterior Lumbar Interbody Fusion is manufactured by Astura Medical.
What is the FDA product code for EL CAPITAN Anterior Lumbar Interbody Fusion?
The FDA product code for EL CAPITAN Anterior Lumbar Interbody Fusion is OVD.
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Related PubMed Literature
PMID: 41839575
A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.
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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.