FDA 510(k) Application Details - K221283

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K221283
Device Name	Pin, Fixation, Smooth
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	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2022
Decision Date	09/06/2022
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