FDA 510(k) Application Details - K200062

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K200062
Device Name	Plate, Fixation, Bone
Applicant	Leith Medical LLC 4705 Eagle Feather Dr Austin, TX 78735 US Other 510(k) Applications for this Company
Contact	Tim Leak 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	01/13/2020
Decision Date	02/22/2021
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