Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K120840 |
Device Name |
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
Applicant |
L&K BIOMED CO., LTD |
#1104, ACE HIGH-END TOWER 3 |
CHA, 371-50 GASAN-DONG |
GEUMCHEON-GU, SEOUL,
KR
153-803
|
|
Applicant Contact |
KI HYANG KIM |
Correspondent |
L&K BIOMED CO., LTD |
#1104, ACE HIGH-END TOWER 3 |
CHA, 371-50 GASAN-DONG |
GEUMCHEON-GU, SEOUL,
KR
153-803
|
|
Correspondent Contact |
KI HYANG KIM |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 03/20/2012 |
Decision Date | 05/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|