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

Humanitarian Device Exemption (HDE)
  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameMETACARPAL PHALANGEAL JOINT IMPLANT
Applicant
Encore Medical L/P. d/b/a DJO Surgical
9800 metric boulevard
austin, TX 78758
HDE NumberH010001
Supplement NumberS001
Date Received11/08/2002
Decision Date12/31/2002
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new manufacturing facility located at rms co. , 8600 evergreen blvd. , minneapolis, minnesota 55433-6036 and a new sterilization facility located at micronet medical, inc. , 1839 buerkle road, st. Paul, mn.
-
-