FDA 510(k) Application Details - K250334

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K250334
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	Kelyniam Global Inc. 97 River Road, Suite A Canton, CT 06019 US Other 510(k) Applications for this Company
Contact	Elise Bozzuto Other 510(k) Applications for this Contact
Regulation Number	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2025
Decision Date	07/25/2025
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