FDA 510(k) Application Details - K250494

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K250494
Device Name	Plate, Fixation, Bone
Applicant	OsteoCentric Technologies 75 West 300 North Suite 150 Logan, UT 84321 US Other 510(k) Applications for this Company
Contact	Todd Evans Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2025
Decision Date	03/18/2025
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