DVX SPINE SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K080876
Device Name DVX SPINE SYSTEM
Applicant
BK MEDITECH CO., LTD.
po box 560
stillwater, 
MN 
55082

Applicant Contact elaine duncan
Correspondent
BK MEDITECH CO., LTD.
po box 560
stillwater, 
MN 
55082

Correspodent Contact elaine duncan
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 03/31/2008
Decision Date 06/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No