FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Eminent Spine 3D Cervical Interbody Fusion System
K Number: K212701
·
Decision Feb 6, 2023
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
11
Review Days
530
Basic Information
- Device Name
- Eminent Spine 3D Cervical Interbody Fusion System
- K Number
- K212701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eminent Spine
- Date Received
- August 25, 2021
- Decision Date
- February 6, 2023
- 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 Eminent Spine
| K Number | Device Name | ||
|---|---|---|---|
| K250894 | Eminent Spine Posterior SI System | Oct 7, 2025 | Substantially Equivalent |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | Apr 28, 2025 | Substantially Equivalent |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | Sep 3, 2024 | Substantially Equivalent |
| K221936 | Standalone ALIF Interbody Fusion System | Oct 17, 2022 | Substantially Equivalent |
| K143365 | Eminent Foot Plate System | Mar 30, 2015 | Substantially Equivalent |
| K133194 | DIAMOND RATTLESNAKE SYSTEM | Jun 26, 2014 | Substantially Equivalent |
| K103068 | KING COBRA ANTERIOR CERVICAL PLATE | Jan 14, 2011 | Substantially Equivalent |
| K100377 | DIAMONDBACK SPINAL SYSTEM | Apr 22, 2010 | Substantially Equivalent |
| K090415 | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM | Jun 1, 2009 | Substantially Equivalent |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | Apr 9, 2009 | Substantially Equivalent |