FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuVasive Modulus ALIF System
K Number: K210271
·
Decision Mar 1, 2021
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
112
Review Days
28
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Basic Information
- Device Name
- NuVasive Modulus ALIF System
- K Number
- K210271
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nu Vasive, Incorporated
- Date Received
- February 1, 2021
- Decision Date
- March 1, 2021
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Nu Vasive, 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 |