MODIFICATION TO:PILOT SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K080502
Device Name MODIFICATION TO:PILOT SPINAL 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 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 02/25/2008
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No