FDA 510(k) Application Details - K221795

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K221795
Device Name	Cerclage, Fixation
Applicant	Neos Surgery SL Parc Technologic del Valles Barcelona 08290 ES Other 510(k) Applications for this Company
Contact	Eduard Garcia Puig Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	10/19/2022
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