MODIFICATION TO:TSRH SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K072317
Device Name MODIFICATION TO:TSRH SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

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

Correspodent Contact lee grant
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 08/20/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls