510(k) K201543
K201543 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Inc. for the device "MAGEC® System". The FDA issued a decision of Substantially Equivalent on July 30, 2020. The device falls under product code PGN (Growing Rod System- Magnetic Actuation), a Class II device regulated under 21 CFR 888.3070. Nuvasive Specialized Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2020
- Date Received
- June 9, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Growing Rod System- Magnetic Actuation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.