FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE COROENT NO-PROFILE SYSTEM
K Number: K112561
·
Decision Mar 13, 2012
Classifications
1
FEI Numbers
254
Registration Numbers
254
Same Product Code
194
Applicant Total
87
Review Days
193
Basic Information
- Device Name
- NUVASIVE COROENT NO-PROFILE SYSTEM
- K Number
- K112561
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NUVASIVE, INC.
- Date Received
- September 2, 2011
- Decision Date
- March 13, 2012
- 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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|---|---|---|---|
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| K141968 | NUVASIVE NVM5 SYSTEM | Nov 14, 2014 | Substantially Equivalent |
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| 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 |