INTREPID SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080083
Device Name INTREPID SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact lee grant
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact lee grant
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 01/11/2008
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls