The following data is part of a premarket notification filed by Bk Meditech, Co., Ltd with the FDA for Mega Plus Mis Spine System.
Device ID | K200981 |
510k Number | K200981 |
Device Name: | Mega Plus MIS Spine System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | BK Meditech, Co., Ltd 58, Eunhaengnamu-ro, Yanggam-myeon, Hwaseong-si, KR 18633 |
Contact | Byoungjun Park |
Correspondent | Nathan Wright Emprical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-14 |
Decision Date | 2020-08-11 |
Summary: | summary |