FDA 510(k) Application Details - K202918

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K202918
Device Name	Plate, Bone
Applicant	Sites Medical, LLC 5865 E State Road 14 Columbia City, IN 46725 US Other 510(k) Applications for this Company
Contact	Greg Stalcup Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	07/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review