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 Bone Cement
510(k) Number K192379
Device Name Hi-Fatigue G Bone Cement
Applicant
Osartis GmbH
Lagerstrasse 11-15
Dieburg,  DE 64807
Applicant Contact Volker Stirnal
Correspondent
Osartis GmbH
Lagerstrasse 11-15
Dieburg,  DE 64807
Correspondent Contact Volker Stirnal
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received08/30/2019
Decision Date 11/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-