FDA 510(k) Application Details - K220199

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K220199
Device Name	Plate, Fixation, Bone
Applicant	Techfit Digital Surgery INC. 1511 Aviation Center Pkwy, Suite 220H Daytona Beach, FL 32114 US Other 510(k) Applications for this Company
Contact	Leidy Johanna Toro-Gonzalez 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	01/24/2022
Decision Date	03/21/2022
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