OSTAPEK VBR SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K072326
Device Name OSTAPEK VBR SYSTEM
Applicant
CO-LIGNE AG
1070 conrad avenue, suite 230
concord, 
CA 
94520

Applicant Contact david schlerf
Correspondent
CO-LIGNE AG
1070 conrad avenue, suite 230
concord, 
CA 
94520

Correspodent Contact david schlerf
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 08/20/2007
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No