FDA 510(k) Application Details - K230850

Device Classification Name	More FDA Info for this Device
510(K) Number	K230850
Device Name	United Orthopedic Knee Patient Specific Instrumentation
Applicant	Enhatch, Inc. 226 Boulevard Hasbrouck Heights, NJ 07604 US Other 510(k) Applications for this Company
Contact	Monica Williams Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OOG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2023
Decision Date	12/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review