TOWERLOX PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K122332
Device Name TOWERLOX PEDICLE SCREW SYSTEM
Applicant
CAPTIVA SPINE
13540 guild ave
apple vally, 
MN 
55124

Applicant Contact rich jansen
Correspondent
CAPTIVA SPINE
13540 guild ave
apple vally, 
MN 
55124

Correspodent Contact rich jansen
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 08/02/2012
Decision Date 10/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No