FDA 510(k) Application Details - K212489

Device Classification Name	More FDA Info for this Device
510(K) Number	K212489
Device Name	BonOs Inject Bone Cement; NEO Pedicle Screw System
Applicant	Neo Medical SA Route de Lausanne 157 A Villette (Lavaux) 1096 CH Other 510(k) Applications for this Company
Contact	Jonas Larsson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2021
Decision Date	10/28/2021
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