• 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 orthopedic stereotaxic instrument
510(k) Number K120867
Device Name VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham,  MA  02767
Applicant Contact laura bleyendaal
Correspondent
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham,  MA  02767
Correspondent Contact laura bleyendaal
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/22/2012
Decision Date 09/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-