FDA 510(k) Application Details - K212391

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K212391
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	MCI Medical Concept Innovation Inc. 4592 North Hiatus Road Sunrise, FL 33351 US Other 510(k) Applications for this Company
Contact	Carlos Lacerda 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	08/02/2021
Decision Date	10/21/2022
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