FDA 510(k) Application Details - K192504

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K192504
Device Name	Plate, Fixation, Bone
Applicant	Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra, FL 32081 US Other 510(k) Applications for this Company
Contact	Rachel Osbeck 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	09/12/2019
Decision Date	10/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review