FDA 510(k) Application Details - K243991

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K243991
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	Total Joint Othopedics, Inc. 1567 E. Stratford Ave. Salt Lake City, UT 84106 US Other 510(k) Applications for this Company
Contact	Bobbi Siddoway Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	JWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2024
Decision Date	03/24/2025
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