FDA 510(k) Application Details - K243658

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K243658
Device Name	Staple, Fixation, Bone
Applicant	Treace Medical Concepts 100 Palmetto Park Place Ponte Vedra, FL 32081 US Other 510(k) Applications for this Company
Contact	Brittany Grochala Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2024
Decision Date	12/26/2024
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