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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K890472
Device Name ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
Applicant
Kinamed, Inc.
10780 Santa Monica Blvd.,
Suite 100
Los Angeles,  CA  90025
Applicant Contact CLARKE, PHD
Correspondent
Kinamed, Inc.
10780 Santa Monica Blvd.,
Suite 100
Los Angeles,  CA  90025
Correspondent Contact CLARKE, PHD
Regulation Number888.3353
Classification Product Code
LZO  
Date Received01/30/1989
Decision Date 09/01/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-