Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K191826
Device Name KeYi Total Hip System
Applicant
Beijing Keyi Medical Device Technology Co., Ltd.
Bldg. 1, 30 Yongchang S. Rd.
Beijing,  CN 100176
Applicant Contact Jenny Jiang
Correspondent
Beijing Keyi Medical Device Technology Co., Ltd.
Bldg. 1, 30 Yongchang S. Rd.
Beijing,  CN 100176
Correspondent Contact Jenny Jiang
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/08/2019
Decision Date 05/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-