FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpineFrontier Lumbar Interbody Fusion Device System
K Number: K193106
·
Decision Jun 19, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
24
Review Days
224
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
- SpineFrontier Lumbar Interbody Fusion Device System
- K Number
- K193106
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinefrontier, Inc.
- Date Received
- November 8, 2019
- Decision Date
- June 19, 2020
- 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 Spinefrontier, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172484 | A-CIFT SoloFuse | May 8, 2018 | Substantially Equivalent |
| K151198 | A-CIFT SoloFuse | Jul 17, 2015 | Substantially Equivalent |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | May 13, 2015 | Substantially Equivalent |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | Apr 24, 2015 | Substantially Equivalent |
| K143377 | PedFuse Pedicle Screw System | Feb 12, 2015 | Substantially Equivalent |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Nov 25, 2014 | Substantially Equivalent |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Oct 20, 2014 | Substantially Equivalent |
| K141337 | ARENA-C | Sep 8, 2014 | Substantially Equivalent |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | May 14, 2014 | Substantially Equivalent |
| K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM | Jan 3, 2014 | Substantially Equivalent |