Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K122518 |
Device Name |
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA 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
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 02/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|