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, Cemented
510(k) Number K890498
Device Name FREEMAN MODULAR HIP STEM RIDGED VERSION
Applicant
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Applicant Contact ROBERT R MOORE
Correspondent
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Correspondent Contact ROBERT R MOORE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received02/01/1989
Decision Date 10/13/1989
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
-
-