FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTICORE
K Number: K140280
·
Decision Sep 5, 2014
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
10
Review Days
213
Basic Information
- Device Name
- FORTICORE
- K Number
- K140280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanovis, LLC
- Date Received
- February 4, 2014
- Decision Date
- September 5, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Nanovis, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Sep 5, 2024 | Substantially Equivalent |
| K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | Jun 2, 2023 | Substantially Equivalent |
| K203452 | Nano FortiFix® System | Dec 22, 2020 | Substantially Equivalent |
| K191822 | Nano FortiCore, FortiCore | Oct 11, 2019 | Substantially Equivalent |
| K171312 | FortiCore® | Jan 22, 2018 | Substantially Equivalent |
| K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R) | Sep 6, 2016 | Substantially Equivalent |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Jun 28, 2016 | Substantially Equivalent |
| K113173 | NANOVIS SPINAL SYSTEM | Jan 19, 2012 | Substantially Equivalent |
| K110442 | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM | Nov 9, 2011 | Substantially Equivalent |