The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for Jasper Spinal Fixation System.
| Device ID | K173645 |
| 510k Number | K173645 |
| Device Name: | JASPER Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GBS Commonwealth Co., Ltd. B-1007-1, Woolim Lion's Valley 168, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
| Contact | Jimmy Kim |
| Correspondent | Jimmy Kim GBS Commonwealth Co., Ltd. #1007-1, Woolim Lion's Valley B, 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 | 2017-11-27 |
| Decision Date | 2018-07-23 |
| Summary: | summary |