LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM


Device Classification Name

plate, bone

510(k) Number K121235
Device Name LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
Applicant
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Applicant Contact jamshed badarpura
Correspondent
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Correspodent Contact jamshed badarpura
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 04/24/2012
Decision Date 01/09/2014
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No