FDA 510(k) Application Details - K241491

Device Classification Name	More FDA Info for this Device
510(K) Number	K241491
Device Name	Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
Applicant	Stryker Corporation (Tornier, S.A.S.) 161 rue Lavoisier Montbonnot-Saint-Martin 38330 FR Other 510(k) Applications for this Company
Contact	Aymen Azaiez 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	05/24/2024
Decision Date	10/10/2024
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