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 Screw, Fixation, Bone
510(k) Number K854336
Device Name MONOFIXATEUR
Applicant
Ortopedia GmbH
One Farragut Sq. S.
Washington,  DC  20006
Applicant Contact LOTHAR GRIESSBACH
Correspondent
Ortopedia GmbH
One Farragut Sq. S.
Washington,  DC  20006
Correspondent Contact LOTHAR GRIESSBACH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/28/1985
Decision Date 03/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-