FDA 510(k) Application Details - K250055

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K250055
Device Name	Plate, Fixation, Bone
Applicant	OrthoNovis, Inc. 1 Hargrove Grade, Suite 2f Palm Coast, FL 32137 US Other 510(k) Applications for this Company
Contact	Ken West 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	01/10/2025
Decision Date	02/06/2025
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