K233593
- 510(k) number
- K233593
- Device name
- MAGEC Spinal Bracing and Distraction System
- Applicant
- Nuvasive Specialized Orthopedics, Incorporated CA · US
- Product code
- PGN — Growing Rod System- Magnetic Actuation
- Decision date
- 2024-02-06
- Date received
- 2023-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233593.pdf
Official FDA record: K233593
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.