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 |