PEZO INTERBODY CAGES SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K103814
Device Name PEZO INTERBODY CAGES SYSTEM
Applicant
ULRICH GMBH & CO. KG
612 trade center blvd
chesterfield, 
MO 
63005

Applicant Contact hans stover
Correspondent
ULRICH GMBH & CO. KG
612 trade center blvd
chesterfield, 
MO 
63005

Correspodent Contact hans stover
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 12/29/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No