FDA 510(k) Application Details - K220463

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K220463
Device Name	Plate, Fixation, Bone
Applicant	4WEB Medical, Inc. 2801 Network Blvd., Suite 620 Frisco, TX 75034 US Other 510(k) Applications for this Company
Contact	Lewis Harrison Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2022
Decision Date	05/18/2022
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