The following data is part of a premarket notification filed by Paonan Biotech Co., Ltd. with the FDA for Pk High Tibial Osteotomy Correction System.
| Device ID | K182285 |
| 510k Number | K182285 |
| Device Name: | PK High Tibial Osteotomy Correction System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | Paonan Biotech Co., Ltd. 3F, No. 50, Lane. 258, Rueiguang Road., Neihu District Taiwan, R.O.C. Taipei City, TW 11491 |
| Contact | Vivi Tsai |
| Correspondent | North Zhong Paonan Biotech Co., Ltd. 3F, No. 50, Lane. 258, Rueiguang Road., Neihu District Taiwan, R.O.C. Taipei City, TW 11491 |
| Product Code | KTW |
| Subsequent Product Code | JDW |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2019-06-20 |