FDA 510(k) Application Details - K220357

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K220357
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 US Other 510(k) Applications for this Company
Contact	Brian Buss Other 510(k) Applications for this Contact
Regulation Number	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2022
Decision Date	08/26/2022
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