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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2020-04-21 under 510(k) 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. The listed applicant is Astura Medical, LLC. The 510(k) number is K192492.

When did EL CAPITAN Anterior Lumber Interbody System receive FDA 510(k) clearance?

EL CAPITAN Anterior Lumber Interbody System received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192492.

Who is the listed applicant for EL CAPITAN Anterior Lumber Interbody System?

The FDA 510(k) record lists Astura Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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