FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROPA Pedicle Screw System
K Number: K180337
·
Decision Mar 14, 2019
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
21
Review Days
400
Basic Information
- Device Name
- EUROPA Pedicle Screw System
- K Number
- K180337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MiRus, LLC
- Date Received
- February 7, 2018
- Decision Date
- March 14, 2019
- 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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