FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE MESH
K Number: K032476
·
Decision Nov 13, 2003
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
91
Review Days
93
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
- NUVASIVE MESH
- K Number
- K032476
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- August 12, 2003
- Decision Date
- November 13, 2003
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQP), ordered by most recent decision date.
VyBrate VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
Vertiwedge® Intraosseous System
FDA 510(k)
FDA Class 2
·Orthopedic
KONG®-TL VBR System and KONG® C VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
DOMINION Expandable Corpectomy System
FDA 510(k)
FDA Class 2
·Orthopedic
VerteLoc Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Ascend VBR System, Ascend NanoTec VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Nuvasive, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240507 | NuVasive AttraX Scaffold | Mar 20, 2024 | Substantially Equivalent |
| K223731 | NuVasive Modulus-C Interbody System | Jan 12, 2023 | Substantially Equivalent |
| K211757 | Simplify Disc | Aug 20, 2021 | Substantially Equivalent |
| K173117 | NuVasive® VersaTie System | Dec 7, 2017 | Substantially Equivalent |
| K141665 | NuVasive CoRoent System | Mar 13, 2015 | Substantially Equivalent |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Feb 20, 2015 | Substantially Equivalent |
| K141968 | NUVASIVE NVM5 SYSTEM | Nov 14, 2014 | Substantially Equivalent |
| K140319 | COROENT TI-C SYSTEM | Oct 9, 2014 | Substantially Equivalent |
| K140162 | AP EXPANDABLE XLIF SYSTEM | Jul 2, 2014 | Substantially Equivalent |
| K140003 | COROENT SMALL INTERBODY SYSTEM | Apr 3, 2014 | Substantially Equivalent |