The following data is part of a premarket notification filed by Bm Korea with the FDA for Galaxy Mis Screw System.
| Device ID | K143110 |
| 510k Number | K143110 |
| Device Name: | GALAXY MIS Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BM KOREA 325-26 DANGJEONG-DONG Gunpo-si, KR 435832 |
| Contact | June Han |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92831 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-06-24 |
| Summary: | summary |