FDA 510(k) Application Details - K241027

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K241027
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	Orthocon, Inc. 700 Fairfield Ave. - Suite 1 Stamford, CT 06902 US Other 510(k) Applications for this Company
Contact	Schrayer Howard 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	04/15/2024
Decision Date	09/26/2024
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