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 | K173180 |
510k Number | K173180 |
Device Name: | Mega Plus Spine System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | BK MEDITECH Co., Ltd. 58, Eunhaengnamu-ro, Yanggam-myeon Hwaseong-si, KR |
Contact | Byoungjun Park |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2018-03-15 |
Summary: | summary |