CLYDESDALES SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112405
Device Name CLYDESDALES SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

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

Correspodent Contact julie bassett
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 08/22/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No