FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMINENT SPINE INTERBODY FUSION SYSTEM
K Number: K090064
·
Decision Apr 9, 2009
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
11
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EMINENT SPINE INTERBODY FUSION SYSTEM
- K Number
- K090064
- 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
- January 9, 2009
- Decision Date
- April 9, 2009
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Feb 6, 2023 | 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 |