VENUS CERVICAL SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K103414
Device Name VENUS CERVICAL SPINAL FIXATION SYSTEM
Applicant
L&K BIOMED CO.,LTD.
#1104 ace high-end tower 3 cha
371-50 gasan-dong geumchoen-gu
seoul, 

KR

153-803

Applicant Contact sun yi lee
Correspondent
L&K BIOMED CO.,LTD.
#1104 ace high-end tower 3 cha
371-50 gasan-dong geumchoen-gu
seoul, 

KR

153-803

Correspodent Contact sun yi lee
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 11/22/2010
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No