FDA 510(k) Application Details - K172617

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K172617
Device Name	Screw, Fixation, Bone
Applicant	Treace Medical Concepts, Inc. 3107 Sawgrass Village Circle Ponte Vedra Beach, FL 32082 US Other 510(k) Applications for this Company
Contact	Rachel Osbeck 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	08/31/2017
Decision Date	10/25/2017
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