FDA 510(k) Application Details - K221943

Device Classification Name	More FDA Info for this Device
510(K) Number	K221943
Device Name	EmbedMed
Applicant	3D LifePrints UK Ltd. The Innovation Hub, Alder Hey Children's NHS Foundation Trust, Eaton Road West Derby, Liverpool, Merseyside L12 2AP GB Other 510(k) Applications for this Company
Contact	Henry Pinchbeck Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2022
Decision Date	02/01/2023
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