FDA 510(k) Application Details - K250712

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K250712
Device Name	Staple, Fixation, Bone
Applicant	Trax Surgical 75 Mill Street Stoughton, MA 02072 US Other 510(k) Applications for this Company
Contact	Stephen Deane 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	03/10/2025
Decision Date	05/14/2025
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