FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE LONG LATERAL SPINAL SYSTEM
K Number: K111410
·
Decision Jun 20, 2011
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
87
Review Days
32
Basic Information
- Device Name
- NUVASIVE LONG LATERAL SPINAL SYSTEM
- K Number
- K111410
- 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
- May 19, 2011
- Decision Date
- June 20, 2011
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
Resolve Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Frida Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
X-PAC® N-GAGE Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Skyway Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Elegance® Anterior Cervical plate
FDA 510(k)
FDA Class 2
·Orthopedic
Cervical Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by NUVASIVE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | Dec 20, 2013 | Substantially Equivalent |
| K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM | Nov 27, 2013 | Substantially Equivalent |
| K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM | Oct 31, 2013 | Substantially Equivalent |
| K131723 | COROENT SINGLE TAB SYSTEM | Sep 20, 2013 | Substantially Equivalent |