CAPSTONE R SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K103731
Device Name CAPSTONE R SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact thao phan
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact thao phan
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 12/22/2010
Decision Date 07/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No