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 |