• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, bone
510(k) Number K122313
Device Name STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
Original Applicant
STRYKER
750 trade centre way
ste 200
portage,  MI  49002
Original Contact rob yamashita
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received08/02/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-