NOVEL SPINAL SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081153
Device Name NOVEL SPINAL SYSTEM
Applicant
MEDYSSEY CO., LTD.
13340 e. firestone blvd.
suite j
santa fe springs, 
CA 
90670

Applicant Contact jung bae bang
Correspondent
MEDYSSEY CO., LTD.
13340 e. firestone blvd.
suite j
santa fe springs, 
CA 
90670

Correspodent Contact jung bae bang
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 04/23/2008
Decision Date 01/30/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No