FDA 510(k) Application Details - K230774

Device Classification Name	More FDA Info for this Device
510(K) Number	K230774
Device Name	PERLA« TL System; TEKTONA« HV US Bone Cement
Applicant	Spineart 3 Chemin de PrΘ Fleuri 1228 Plan Les Ouates Geneva CH Other 510(k) Applications for this Company
Contact	Franck Pennesi 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	03/21/2023
Decision Date	06/23/2023
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