KIMBA MINI


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080349
Device Name KIMBA MINI
Applicant
SIGNUS MEDIZINTECHNIK GMBH
4050 olson memorial hwy
suite 350
minneapolis, 
MN 
55422

Applicant Contact alan alexander
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
4050 olson memorial hwy
suite 350
minneapolis, 
MN 
55422

Correspodent Contact alan alexander
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 02/11/2008
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No