E3D-C Interbody System
K-Number: K260038 · 2026-02-04
ApplicantEvolution Spine
Decision Date2026-02-04
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
E3D-C Interbody System is a medical device manufactured by Evolution Spine. It received FDA 510(k) clearance on 2026-02-04 under approval number K260038. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E3D-C Interbody System?
E3D-C Interbody System is a medical device that received FDA 510(k) clearance on 2026-02-04. It is manufactured by Evolution Spine. The 510(k) number is K260038.
When was E3D-C Interbody System approved by the FDA?
E3D-C Interbody System received FDA 510(k) clearance on 2026-02-04, under approval number K260038.
What company makes E3D-C Interbody System?
E3D-C Interbody System is manufactured by Evolution Spine.
What is the FDA product code for E3D-C Interbody System?
The FDA product code for E3D-C Interbody System is OVE.
Related Clinical Trials
Other Devices by Evolution Spine
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K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated
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K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.
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.