FDA 510(k) Application Details - K242315

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate   More FDA Info for this Device
510(K) Number	K242315
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant	United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu 30075 TW Other 510(k) Applications for this Company
Contact	Lois Ho Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2024
Decision Date	05/01/2025
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