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 |