PREFERENCE PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081296
Device Name PREFERENCE PEDICLE SCREW SYSTEM
Applicant
US SPINE
13540 guild ave
apple valley, 
MN 
55124

Applicant Contact richard jansen, pharm. d.
Correspondent
US SPINE
13540 guild ave
apple valley, 
MN 
55124

Correspodent Contact richard jansen, pharm. d.
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received 05/07/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No