FDA 510(k) Application Details - K231386

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K231386
Device Name	Wax,Bone
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2023
Decision Date	07/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review