Cleared Special

K262094 - E3D™-C Interbody System

K262094 is an FDA 510(k) clearance for E3D-C Interbody System, manufactured by Evolution Spine. The device is a Class 2 Orthopedic device with product code OVE cleared through the Special 510(k) pathway after a 30-day FDA review.

K262094 · Evolution Spine · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2026
Decision
30d
Days
Class 2
Risk

K262094 is an FDA 510(k) clearance for the E3D™-C Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Evolution Spine (Dallas, US). The FDA issued a Cleared decision on July 22, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Evolution Spine devices

FDA 510(k) Submission Details - K262094

510(k) Number K262094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date July 22, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K262094.
Pisces-SC Standalone Cervical Interbody System
K261882 · Osseus Fusions Systems, LLC · Aug 2026
ZSAlign Cervical Interbody System
K261451 · Zsfab, Inc. · Jul 2026
DeltaNEC Interbody System
K261279 · Nexus Spine · Jun 2026
CONDUIT™ ZERO-P™ VA Secured Spacer System
K252982 · Avalign Technologies, Inc. · Jun 2026
NeckTune™ 3D SA Cervical Cage
K260036 · Medyssey Co, Ltd. · Jun 2026
SABER-C System
K260660 · Elevation Spine · Apr 2026