The following data is part of a premarket notification filed by Shanghai Reach Medical Instrument Co., Ltd with the FDA for Sterile Posterior Spinal Fixation System.
| Device ID | K221745 |
| 510k Number | K221745 |
| Device Name: | Sterile Posterior Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Shanghai REACH Medical Instrument Co., Ltd Building 13, No.999 Jiangyue Road Minhang District Shanghai, CN 201114 |
| Contact | Mingsha Ye |
| Correspondent | Huifang Zhao Sinow Medical AS Hoyteknologisenteret, Thormohlens gate 55 Bergen, NO 5006 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-16 |
| Decision Date | 2022-08-31 |