CD HORIZON(R) SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K112555
Device Name CD HORIZON(R) SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

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

Correspodent Contact chris mckee
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received 09/02/2011
Decision Date 09/27/2011
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No