FDA 510(k) Application Details - K241077

Device Classification Name	More FDA Info for this Device
510(K) Number	K241077
Device Name	DeGen Medical Patient Specific Implant (PSI) System
Applicant	DeGen Medical 1321-C North Cashua Drive Florence, SC 29501 US Other 510(k) Applications for this Company
Contact	Black Craig Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2024
Decision Date	10/29/2024
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