FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NUVASIVE CEMENT RESTRICTOR
K Number: K032180
·
Decision Oct 7, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
91
Review Days
82
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Basic Information
- Device Name
- NUVASIVE CEMENT RESTRICTOR
- K Number
- K032180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- July 17, 2003
- Decision Date
- October 7, 2003
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Nuvasive, Inc.
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|---|---|---|---|
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| 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 |