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 pin, fixation, smooth
510(k) Number K094043
Device Name LIGAMENTOTAXOR
Applicant
AREX USA
1335 MERRYBROOK RD.
COLLEGEVILLE,  PA  19426
Applicant Contact ELLEN HOKANSON
Correspondent
AREX USA
1335 MERRYBROOK RD.
COLLEGEVILLE,  PA  19426
Correspondent Contact ELLEN HOKANSON
Regulation Number888.3040
Classification Product Code
HTY  
Date Received12/31/2009
Decision Date 08/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-