E3D-A Interbody System
K-Number: K240368 · 2024-05-15
ApplicantEvolution Spine
Decision Date2024-05-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
E3D-A Interbody System is a medical device manufactured by Evolution Spine. It received FDA 510(k) clearance on 2024-05-15 under approval number K240368. 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 E3D-A Interbody System?
E3D-A Interbody System is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Evolution Spine. The 510(k) number is K240368.
When was E3D-A Interbody System approved by the FDA?
E3D-A Interbody System received FDA 510(k) clearance on 2024-05-15, under approval number K240368.
What company makes E3D-A Interbody System?
E3D-A Interbody System is manufactured by Evolution Spine.
What is the FDA product code for E3D-A Interbody System?
The FDA product code for E3D-A Interbody System is OVD.
Related Clinical Trials
Other Devices by Evolution Spine
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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.