TSRH SPINAL SYSTEMS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111942
Device Name TSRH SPINAL SYSTEMS
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact lila joe
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact lila joe
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received 07/08/2011
Decision Date 08/30/2011
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