Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K153656 |
Device Name |
PathLoc-SI Joint Fusion System |
Applicant |
L&K BIOMED Co., Ltd. |
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
Giheung-gu, Yongin-si,
KR
446-916
|
|
Applicant Contact |
Yerim An |
Correspondent |
L&K BIOMED Co., Ltd. |
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
Giheung-gu, Yongin-si,
KR
446-916
|
|
Correspondent Contact |
Yerim An |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/21/2015 |
Decision Date | 11/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|