The following data is part of a premarket notification filed by Bk Meditech Co., Ltd with the FDA for Mega Plus Spine System.
| Device ID | K183080 |
| 510k Number | K183080 |
| Device Name: | Mega Plus Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BK Meditech Co., Ltd 58, Eunhaengnamu-ro Yanggam-myeon Hwaseong-si, KR 18633 |
| Contact | Meredith Lee May |
| Correspondent | Meredith L. May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2018-12-10 |
| Summary: | summary |