Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

E3D™-C Interbody System

K-Number: K262094 · 2026-07-22

ApplicantEvolution Spine
Decision Date2026-07-22
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E3D™-C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262094. 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 2026-07-22. The listed applicant is Evolution Spine. The 510(k) number is K262094.

When did E3D™-C Interbody System receive FDA 510(k) clearance?

E3D™-C Interbody System received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262094.

Who is the listed applicant for E3D™-C Interbody System?

The FDA 510(k) record lists Evolution Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E3D™-C Interbody System?

The FDA product code for E3D™-C Interbody System is OVE.

Other records listing Evolution Spine as applicant

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.

K260038E3D™-C Interbody SystemK250167Evolution Spine Navigation InstrumentsK241846E3D™-C Interbody SystemK240368E3D™-A Interbody SystemK232432E3D™-A Interbody SystemK223146EVOLUTION SPINE Interbody System

View all 14 devices →

Related Devices (Code: OVE)

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.

K261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation SpineK253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.

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.

↑