CRESCENT (R) SPINAL SYSTEM TITANIUM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110543
Device Name CRESCENT (R) SPINAL SYSTEM TITANIUM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

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

Correspodent Contact becky ronner
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 02/25/2011
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No