MONOPOLY PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K081108
Device Name MONOPOLY PEDICLE SCREW SYSTEM
Applicant
SIGNUS MEDICAL LLC.
1331 h st nw
suite 1200
washington, 
DC 
20005

Applicant Contact richard jansen
Correspondent
SIGNUS MEDICAL LLC.
1331 h st nw
suite 1200
washington, 
DC 
20005

Correspodent Contact richard jansen
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 04/18/2008
Decision Date 07/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No