FDA 510(k) Application Details - K232265

Device Classification Name	More FDA Info for this Device
510(K) Number	K232265
Device Name	BLUEPRINTÖ Patient Specific Instrumentation
Applicant	Tornier SAS 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	07/31/2023
Decision Date	02/21/2024
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