VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110783
Device Name VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
Applicant
L & K BIOMED CO., LTD
room 1104, ace high-end tower3
371-50 gasan-dong, geumcheon-g
seoul, 

KR

153803

Applicant Contact hee kyeong joo
Correspondent
L & K BIOMED CO., LTD
room 1104, ace high-end tower3
371-50 gasan-dong, geumcheon-g
seoul, 

KR

153803

Correspodent Contact hee kyeong joo
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/21/2011
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No