FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGEC® Spinal Bracing and Distraction System
K Number: K160352
·
Decision Oct 21, 2016
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
20
Review Days
256
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Basic Information
- Device Name
- MAGEC® Spinal Bracing and Distraction System
- K Number
- K160352
- 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
- February 8, 2016
- Decision Date
- October 21, 2016
- 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.
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MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
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FDA Class 2
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