FDA 510(k) Application Details - K234040

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K234040
Device Name	Screw, Fixation, Bone
Applicant	TriMed, INC 27533 Avenue Hopkins Valencia, CA 91355 US Other 510(k) Applications for this Company
Contact	David Medoff 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	12/21/2023
Decision Date	01/18/2024
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