The following data is part of a premarket notification filed by Paonan Biotech Co., Ltd. with the FDA for Trend Ii Spinal Fixation System- Step Series.
| Device ID | K180226 |
| 510k Number | K180226 |
| Device Name: | TREND II Spinal Fixation System- STEP Series |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Paonan Biotech Co., Ltd. 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District, Taipei, R.O.C. Taipei, TW 11491 |
| Contact | Vivi Tsai |
| Correspondent | Vivi Tsai Paonan Biotech Co., Ltd. 3F, No. 50, Lane 258, Rueiguang Road Neihu District Taipei City 114, TW 11491 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-26 |
| Decision Date | 2018-07-25 |
| Summary: | summary |