FDA 510(k) Application Details - K202326

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K202326
Device Name	Screw, Fixation, Bone
Applicant	Bespa Global, LLC 9 Rand Road Caoe Elizabeth, ME 04107 US Other 510(k) Applications for this Company
Contact	Lisa Viele Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2020
Decision Date	11/09/2021
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