FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
M.U.S.T. MINI Posterior Cervical Screws System
K Number: K200130
·
Decision Feb 10, 2020
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
165
Review Days
20
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Basic Information
- Device Name
- M.U.S.T. MINI Posterior Cervical Screws System
- K Number
- K200130
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- January 21, 2020
- Decision Date
- February 10, 2020
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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