The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Castleloc Spinal Fixation System.
Device ID | K162801 |
510k Number | K162801 |
Device Name: | CastleLoc Spinal Fixation System |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | L&K BIOMED CO., LTD. #201, 202 16-25, DONGBAEKJUNGANG-RO 16 BEON-GIL Giheung-gu, Yongin-si, KR 17015 |
Contact | Yerim An |
Correspondent | Yerim An L&K BIOMED CO., LTD. #201, 202 16-25, DONGBAEKJUNGANG-RO 16 BEON-GIL Giheung-gu, Yongin-si, KR 17015 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-05 |
Decision Date | 2016-11-03 |
Summary: | summary |