E3D™-C Interbody System

510(k) Number

K260038 ↗

FDA product code

OVE

Device class

Class II

Regulation

21 CFR Part 888.3080

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

• SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION by Spineart
• ACDF Stand Alone Cervical 03.18.118 by Medacta International SA
• ACDF Stand Alone Cervical 03.18.611 by Medacta International SA
• NuVasive CoRoent Small Interlock II System by Nu Vasive, Incorporated
• RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System by MIRUS LLC
• CAVUX CervicalCage-L SA System by Providence Medical Technology
• Amendia Stand-Alone Cervical System by Amendia, Inc.
• STALIF C by Centinel Spine, LLC
• Endoskeleton TCS Interbody Fusion Device by Titan Spine, Inc.
• CoRoent Small Interlock System by Nu Vasive, Incorporated

• E3D-C Interbody System 130G-XL0706

  Class II

  FDA 510(k) ×2 Active Cleared 12 Aug 2024 GUDID on market

• E3D-C Interbody System 130G-XL0705

  Class II

  FDA 510(k) ×2 Active Cleared 12 Aug 2024 GUDID on market

• E3D-C Interbody System 130G-XL0707

  Class II

  FDA 510(k) ×2 Active Cleared 12 Aug 2024 GUDID on market

• E3D-C Interbody System 130G-XL0708

  Class II

  FDA 510(k) ×2 Active Cleared 12 Aug 2024 GUDID on market

See all devices from Evolution Spine, LLC →