FDA 510(k) Application Details - K233593

Device Classification Name	More FDA Info for this Device
510(K) Number	K233593
Device Name	MAGEC Spinal Bracing and Distraction System
Applicant	NuVasive Specialized Orthopedics, Incorporated 101 Enterprise Suite 100 Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Miriam Cervantes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2023
Decision Date	02/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review