The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for The Jasper Spinal Fixation System Ii.
Device ID | K190762 |
510k Number | K190762 |
Device Name: | The JASPER Spinal Fixation System II |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
Contact | Jimmy Kim |
Correspondent | Jimmy Kim GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-25 |
Decision Date | 2019-06-19 |