CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111264
Device Name CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact regina holmes
Correspondent
MEDTRONIC SOFAMOR DANEK USA
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact regina holmes
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 05/04/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No