FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuVasive NuvaLine
K Number: K192435
·
Decision Sep 26, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
73
Review Days
21
Basic Information
- Device Name
- NuVasive NuvaLine
- K Number
- K192435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NuVasive, Incorporated
- Date Received
- September 5, 2019
- Decision Date
- September 26, 2019
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by NuVasive, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | Jul 11, 2023 | Substantially Equivalent |
| K230894 | NuVasive Modulus ALIF System | Jun 16, 2023 | Substantially Equivalent |
| K230989 | Rod Registration Frame | May 5, 2023 | Substantially Equivalent |
| K223181 | NuVasive Reline System | Jan 11, 2023 | Substantially Equivalent |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | Oct 21, 2022 | Substantially Equivalent |
| K221388 | NuVasive Reline Cervical System | Sep 9, 2022 | Substantially Equivalent |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Jun 21, 2022 | Substantially Equivalent |
| K213654 | NuVasive Reline Cervical System | Feb 23, 2022 | Substantially Equivalent |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | Dec 23, 2021 | Substantially Equivalent |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nov 3, 2021 | Substantially Equivalent |