FDA 510(k) Application Details - K242671

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K242671
Device Name	Screw, Fixation, Bone
Applicant	Treace Medical Concepts Inc. 100 Palmetto Park Place Ponte Vedra, FL 32081 US Other 510(k) Applications for this Company
Contact	Melissa Coloroso 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	09/06/2024
Decision Date	10/04/2024
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