The following data is part of a premarket notification filed by Paonan Biotech Co., Ltd. with the FDA for Paonan Armstrong Posterior Spinal Fixation System.
| Device ID | K161225 |
| 510k Number | K161225 |
| Device Name: | Paonan Armstrong Posterior Spinal Fixation System |
| 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 | Yi-jhen Tsai |
| Correspondent | Vivi Tsai Paonan Biotech Co., Ltd. 3F, NO.50, LANE 258, RUEIGUANG RD. Neihu District, Taipei City Taipei City, TW 114 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2017-08-11 |
| Summary: | summary |