FDA 510(k) Application Details - K200709

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K200709
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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	888.3390   More FDA Info for this Regulation Number
Classification Product Code	KWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2020
Decision Date	04/17/2020
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