The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for Prase Mis Spinal System.
| Device ID | K182059 |
| 510k Number | K182059 |
| Device Name: | Prase MIS Spinal 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, Seoul, 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 | 2018-07-31 |
| Decision Date | 2018-10-04 |
| Summary: | summary |