FDA 510(k) Application Details - K232771

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K232771
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	Orthocon, Inc. 700 Fairfield Avenue - Suite 1 Stamford, CT 06902 US Other 510(k) Applications for this Company
Contact	Aniq Darr Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	GXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2023
Decision Date	02/16/2024
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