• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • 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 PMA to get an up-to-date view of this device.
 
DeviceFOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM
Classification Nameglenoid fossa prosthesis
Generic Nameglenoid fossa prosthesis
Regulation Number872.3950
Applicant
NEXUS CMF, LLC
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000035
Supplement NumberS002
Date Received06/20/2002
Decision Date09/12/2002
Product Code
MPI
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the "crystal clear anatomical model package insert. ".
-
-