FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K Number: K133052
·
Decision Dec 20, 2013
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
91
Review Days
84
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Basic Information
- Device Name
- AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
- K Number
- K133052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- September 27, 2013
- Decision Date
- December 20, 2013
- Product Code
- PEK
- 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 |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
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