The following data is part of a premarket notification filed by Changzhou Geasure Medical Apparatus And Instruments Co., Ltd with the FDA for Spinal Inner Fixation System.
| Device ID | K222031 |
| 510k Number | K222031 |
| Device Name: | Spinal Inner Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Changzhou Geasure Medical Apparatus And Instruments Co., Ltd No. 12, Jinfeng Road West Taihu Science And Technology Industrial Park Changzhou, CN 213149 |
| Contact | Jing Huang |
| Correspondent | Xiaoqing Xue Sinow Medical AS Vestre Fantoftasen 44, 5072, Bergen, Norway Bergen, NO |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-10-28 |