MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080429
Device Name MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact lila joe
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact lila joe
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 02/19/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No