MEGA SPINE SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K072436
Device Name MEGA SPINE SYSTEM
Applicant
BK MEDITECH CO., LTD.
25041 farrier circle
laguna hills, 
CA 
92653

Applicant Contact henry yang
Correspondent
BK MEDITECH CO., LTD.
25041 farrier circle
laguna hills, 
CA 
92653

Correspodent Contact henry yang
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 08/30/2007
Decision Date 11/01/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No