FDA 510(k) Application Details - K242307

Device Classification Name	More FDA Info for this Device
510(K) Number	K242307
Device Name	ACHIEVE Partial Knee System
Applicant	Ignite OrthoMotion 700 Park Avenue Suite F Winona Lake, IN 46590 US Other 510(k) Applications for this Company
Contact	Russell Parrott Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2024
Decision Date	12/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review