PLATEAU SPACER SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080411
Device Name PLATEAU SPACER SYSTEM
Applicant
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates, 
IL 
60169

Applicant Contact rebecca m brooks
Correspondent
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates, 
IL 
60169

Correspodent Contact rebecca m brooks
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 02/15/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No