FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIP MIS INTERSPINOUS FUSION SYSTEM
K Number: K133091
·
Decision Nov 27, 2013
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
3
Review Days
58
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Basic Information
- Device Name
- ZIP MIS INTERSPINOUS FUSION SYSTEM
- K Number
- K133091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aurora Spine
- Date Received
- September 30, 2013
- Decision Date
- November 27, 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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