FDA 510(k) Application Details - K203108

Device Classification Name	More FDA Info for this Device
510(K) Number	K203108
Device Name	Ignite Stemless Anatomic Shoulder System
Applicant	Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 US Other 510(k) Applications for this Company
Contact	Matt Purdy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2020
Decision Date	07/16/2021
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