MAGEC Spinal Bracing and Distraction System— 510(k) K233593
Substantially EquivalentNuvasive Specialized Orthopedics, Incorporated
FDA 510(k) clearance K233593 for MAGEC Spinal Bracing and Distraction System, Substantially Equivalent on 2024-02-06. Applicant: Nuvasive Specialized Orthopedics, Incorporated.
Clearance details
- Applicant
- Nuvasive Specialized Orthopedics, Incorporated
- Product code
- Code PGN
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alisa Viejo, CA, US
Adverse events under product code PGN
product code PGN- Injury
- 253
- Malfunction
- 633
- Total
- 886
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.