FDA 510(k) Application Details - K243302

Device Classification Name	More FDA Info for this Device
510(K) Number	K243302
Device Name	3DMatrix DynaFlex (DynaFlex)
Applicant	PrintBio, Inc. 51-36 35th Street Long Island City, NY 11101 US Other 510(k) Applications for this Company
Contact	Janet Vargo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	05/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review