FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K Number: K052376
·
Decision Sep 23, 2005
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
145
Review Days
24
Basic Information
- Device Name
- MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
- K Number
- K052376
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC SOFAMOR DANEK
- Date Received
- August 30, 2005
- Decision Date
- September 23, 2005
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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