FDA 510(k) Application Details - K242149

Device Classification Name	More FDA Info for this Device
510(K) Number	K242149
Device Name	NovoSorb« MTX
Applicant	PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne Melbourne 3207 AU Other 510(k) Applications for this Company
Contact	Tarun Nekkenti Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2024
Decision Date	03/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review