FDA 510(k) Application Details - K203472

Device Classification Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented   More FDA Info for this Device
510(K) Number	K203472
Device Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant	Kyocera Medical Technologies, Inc. 1200 California St., Suite 210 Redlands, CA 92374 US Other 510(k) Applications for this Company
Contact	Anthony DeBenedictis Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	OQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2020
Decision Date	04/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review