FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOL® ha-C Cervical Interbody Fusion System
K Number: K180674
·
Decision Jun 25, 2018
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
11
Review Days
102
Basic Information
- Device Name
- EVOL® ha-C Cervical Interbody Fusion System
- K Number
- K180674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cutting Edge Spine, LLC
- Date Received
- March 15, 2018
- Decision Date
- June 25, 2018
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Cutting Edge Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | Mar 12, 2025 | Substantially Equivalent |
| K230689 | T-FIX 3DSI Joint Fusion System | Apr 5, 2023 | Substantially Equivalent |
| K214123 | T-FIX® 3DSI Joint Fusion System | Jun 24, 2022 | Substantially Equivalent |
| K200991 | EVOL Spinal Interbody System | May 13, 2020 | Substantially Equivalent |
| K200552 | EVOS Lumbar Interbody System | Apr 2, 2020 | Substantially Equivalent |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | Jan 6, 2020 | Substantially Equivalent |
| K190025 | EVOL® -SI Joint Fusion System | Aug 12, 2019 | Substantially Equivalent |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | May 4, 2018 | Substantially Equivalent |
| K150321 | EVOS Lumbar Interbody System | Jul 13, 2015 | Substantially Equivalent |
| K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE | Apr 28, 2011 | Substantially Equivalent |