FDA 510(k) Application Details - K221048

Device Classification Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K221048
Device Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Applicant	Episurf Medical, Inc. 220 E 42nd Street, Suite 409A New York, NY 10017 US Other 510(k) Applications for this Company
Contact	Katarina Flodstrom Other 510(k) Applications for this Contact
Regulation Number	888.3540   More FDA Info for this Regulation Number
Classification Product Code	KRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2022
Decision Date	12/23/2022
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