FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K Number: K171170
·
Decision May 25, 2017
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
87
Review Days
34
Basic Information
- Device Name
- M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
- K Number
- K171170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International SA
- Date Received
- April 21, 2017
- Decision Date
- May 25, 2017
- 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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