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 Plate, Bone
510(k) Number K092743
Device Name THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
Applicant
Stryker Craniomaxillofacial
750 Trade Centre Way
Suite 200
Kalamazoo,  MI  49001
Applicant Contact ROBERT YAMASHITA
Correspondent
Stryker Craniomaxillofacial
750 Trade Centre Way
Suite 200
Kalamazoo,  MI  49001
Correspondent Contact ROBERT YAMASHITA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/08/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-