MODIFICATION TO 4CIS VANE SPINE SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K081145
Device Name MODIFICATION TO 4CIS VANE SPINE SYSTEM
Applicant
SOLCO BIOMEDICAL CO., LTD.
155 gibbs st., suite 512
rockville, 
MD 
20850

Applicant Contact saeyoung ahn
Correspondent
SOLCO BIOMEDICAL CO., LTD.
155 gibbs st., suite 512
rockville, 
MD 
20850

Correspodent Contact saeyoung ahn
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 04/22/2008
Decision Date 11/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No