The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis® Chiron Spinal Fixation System.
Device ID | K190471 |
510k Number | K190471 |
Device Name: | 4CIS® Chiron Spinal Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Solco Biomedical Co., Ltd. 154 Seotan-Ro, Seotan-Myeon Pyeongtaek, KR 17704 |
Contact | Kim Il |
Correspondent | Hwi-geun Yu First Gold Corp. 154, Seotan-ro, Gyeonggi-do Pyeongtaek-si, Gyeonggi-do, KR 17704 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-26 |
Decision Date | 2019-07-24 |
Summary: | summary |