FDA 510(k) Application Details - K233482

Device Classification Name	More FDA Info for this Device
510(K) Number	K233482
Device Name	Equinoxe« Central Screw Baseplate System
Applicant	Exactech Inc. 2320 NW 66th Court Gainesville, FL 32653 US Other 510(k) Applications for this Company
Contact	Liz Howell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2023
Decision Date	07/18/2024
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