Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
More FDA Info for this Device |
510(K) Number |
K201660 |
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 |
06/18/2020 |
Decision Date |
07/16/2020 |
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 |
|