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, Hemi-, Femoral, Metal
510(k) Number K030972
Device Name FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
Applicant
Disc-O-Tech Medical Technologies, Ltd.
3 Hasadnaot
Herzelia,  IL 46728
Applicant Contact HILA WACHSLER-AVRAHAMI
Correspondent
Disc-O-Tech Medical Technologies, Ltd.
3 Hasadnaot
Herzelia,  IL 46728
Correspondent Contact HILA WACHSLER-AVRAHAMI
Regulation Number888.3360
Classification Product Code
KWL  
Date Received03/28/2003
Decision Date 05/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-