FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nano FortiCore, FortiCore
K Number: K191822
·
Decision Oct 11, 2019
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
10
Review Days
95
Basic Information
- Device Name
- Nano FortiCore, FortiCore
- K Number
- K191822
- 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
- July 8, 2019
- Decision Date
- October 11, 2019
- 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 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 |
| 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 |
| K140280 | FORTICORE | Sep 5, 2014 | Substantially Equivalent |
| K113173 | NANOVIS SPINAL SYSTEM | Jan 19, 2012 | Substantially Equivalent |
| K110442 | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM | Nov 9, 2011 | Substantially Equivalent |