FDA 510(k) Application Details - K241983

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K241983
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	Orthopediatrics Canada ULC dba Pega Medical 1111 Autoroute Chomedey Laval H7W 5J8 CA Other 510(k) Applications for this Company
Contact	Enrique Garcia Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2024
Decision Date	02/21/2025
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