The following data is part of a premarket notification filed by Corentec Co., Ltd. with the FDA for Lospa® Is™ Spinal Fixation System.
| Device ID | K200267 |
| 510k Number | K200267 |
| Device Name: | LOSPA® IS™ Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, KR 31056 |
| Contact | Sungwon Yang |
| Correspondent | Sungwon Yang Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, KR 31056 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-03-06 |