FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGEC® System
K Number: K201543
·
Decision Jul 30, 2020
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
8
Applicant Total
19
Review Days
51
Basic Information
- Device Name
- MAGEC® System
- K Number
- K201543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NuVasive Specialized Orthopedics, Inc.
- Date Received
- June 9, 2020
- Decision Date
- July 30, 2020
- Product Code
- PGN
- 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 |
|---|---|---|---|
| PGN | Growing Rod System- Magnetic Actuation | FDA class 2 | Orthopedic |
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