SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111820
Device Name SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
Applicant
BM KOREA CO., LTD.
951 starbuck st. unit j
fullerton, 
CA 
92833

Applicant Contact priscilla chung
Correspondent
BM KOREA CO., LTD.
951 starbuck st. unit j
fullerton, 
CA 
92833

Correspodent Contact priscilla chung
Regulation Number 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received 06/28/2011
Decision Date 03/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No