FDA 510(k) Application Details - K251472

Device Classification Name	Fastener, Plate, Cranioplasty   More FDA Info for this Device
510(K) Number	K251472
Device Name	Fastener, Plate, Cranioplasty
Applicant	Inion Oy LΣΣkΣrinkatu 2 Tampere FI-33520 FI Other 510(k) Applications for this Company
Contact	Hanne KankaanpΣΣ Other 510(k) Applications for this Contact
Regulation Number	882.5360   More FDA Info for this Regulation Number
Classification Product Code	HBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2025
Decision Date	07/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review