FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE NVM5 SYSTEM
K Number: K141968
·
Decision Nov 14, 2014
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
34
Applicant Total
91
Review Days
116
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Basic Information
- Device Name
- NUVASIVE NVM5 SYSTEM
- K Number
- K141968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- July 21, 2014
- Decision Date
- November 14, 2014
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| 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 |
| K140319 | COROENT TI-C SYSTEM | Oct 9, 2014 | Substantially Equivalent |
| K140162 | AP EXPANDABLE XLIF SYSTEM | Jul 2, 2014 | Substantially Equivalent |
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| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | Dec 20, 2013 | Substantially Equivalent |