FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGEC® System
K Number: K171791
·
Decision Aug 31, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
4
Review Days
76
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAGEC® System
- K Number
- K171791
- 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, Incorporated
- Date Received
- June 16, 2017
- Decision Date
- August 31, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGN), ordered by most recent decision date.
MAGEC Spinal Bracing and Distraction System
FDA 510(k)
FDA Class 2
·Orthopedic
MAGEC® System
FDA 510(k)
FDA Class 2
·Orthopedic
MAGEC® Spinal Bracing and Distraction System
FDA 510(k)
FDA Class 2
·Orthopedic
MAGEC® Spinal Bracing and Distraction System
FDA 510(k)
FDA Class 2
·Orthopedic
MAGEC 2 Spinal Bracing and Distraction System
FDA 510(k)
FDA Class 2
·Orthopedic
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic