Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K132101 |
Device Name |
ANAX 5.5 SPINAL SYSTEM |
Applicant |
U & I CORPORATION |
20, SANDAN-RO, 76BEON-GIL (RD) |
UIJEONGBU-SI, GYEONGGI-DO,
KR
480-859
|
|
Applicant Contact |
YOUNG-GEUN KIM |
Correspondent |
U & I CORPORATION |
20, SANDAN-RO, 76BEON-GIL (RD) |
UIJEONGBU-SI, GYEONGGI-DO,
KR
480-859
|
|
Correspondent Contact |
YOUNG-GEUN KIM |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/08/2013 |
Decision Date | 11/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|