FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Mont Blanc and Mont Blanc MIS Spinal Systems
K Number: K161387
·
Decision Aug 4, 2016
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
2
Review Days
77
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Basic Information
- Device Name
- Mont Blanc and Mont Blanc MIS Spinal Systems
- K Number
- K161387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineway SA
- Date Received
- May 19, 2016
- Decision Date
- August 4, 2016
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Spineway SA
| K Number | Device Name | ||
|---|---|---|---|
| K191726 | mont blanc & mont blanc MIS Spinal Systems | Sep 12, 2019 | Substantially Equivalent |