SFC VERTEBRAL BODY REPLACEMENT


Device Classification Name

spinal vertebral body replacement device

510(k) Number K110153
Device Name SFC VERTEBRAL BODY REPLACEMENT
Applicant
KONIGSEE IMPLANTATE GMBH
1331 h street nw, 12th floor
washington, 
DC 
20005

Applicant Contact justin eggleton
Correspondent
KONIGSEE IMPLANTATE GMBH
1331 h street nw, 12th floor
washington, 
DC 
20005

Correspodent Contact justin eggleton
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 01/19/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No