The following data is part of a premarket notification filed by Taeyeon Medical Co., Ltd. with the FDA for Balex Bone Expander System.
| Device ID | K202027 |
| 510k Number | K202027 |
| Device Name: | Balex Bone Expander System |
| Classification | Arthroscope |
| Applicant | Taeyeon Medical Co., Ltd. 132-1 Donghwagongdan-Ro, Munmak-eup Wonju-si, KR 26365 |
| Contact | Sin-ae Kang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | HRX |
| Subsequent Product Code | HXG |
| Subsequent Product Code | NDN |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-22 |
| Decision Date | 2021-02-03 |