FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERTIFLEX SPINAL SCREW SYSTEM
K Number: K062670
·
Decision Jan 12, 2007
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
2
Review Days
127
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Basic Information
- Device Name
- VERTIFLEX SPINAL SCREW SYSTEM
- K Number
- K062670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vertiflex (Tm), Incorporated
- Date Received
- September 7, 2006
- Decision Date
- January 12, 2007
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Vertiflex (Tm), Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K070218 | VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) | Apr 6, 2007 | Substantially Equivalent |