FDA 510(k) Application Details - K233567

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K233567
Device Name	Screw, Fixation, Bone
Applicant	Flower Orthopedics Corporation DBA Conventus Flower Ortho 100 Witmer Road Suite 280 Suite 280 Horsham, PA 19044 US Other 510(k) Applications for this Company
Contact	Christina Rovaldi 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	11/06/2023
Decision Date	11/22/2024
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