FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E3D-C Interbody System
K Number: K260038
·
Decision Feb 4, 2026
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
8
Review Days
29
Basic Information
- Device Name
- E3D-C Interbody System
- K Number
- K260038
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Evolution Spine
- Date Received
- January 6, 2026
- Decision Date
- February 4, 2026
- Product Code
- OVE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Evolution Spine
| K Number | Device Name | ||
|---|---|---|---|
| K250167 | Evolution Spine Navigation Instruments | Aug 18, 2025 | Substantially Equivalent |
| K241846 | E3D-C Interbody System | Aug 12, 2024 | Substantially Equivalent |
| K240368 | E3D-A Interbody System | May 15, 2024 | Substantially Equivalent |
| K232432 | E3D-A Interbody System | Jan 30, 2024 | Substantially Equivalent |
| K223146 | EVOLUTION SPINE Interbody System | Feb 7, 2023 | Substantially Equivalent |
| K220275 | EMERGE Anterior Cervical Plate System | Mar 18, 2022 | Substantially Equivalent |
| K212405 | EMERGE Anterior Cervical Plate System | Sep 30, 2021 | Substantially Equivalent |