The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Balteum - One™ Lumbar Plate System.
| Device ID | K213820 |
| 510k Number | K213820 |
| Device Name: | BALTEUM - ONE™ Lumbar Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Huvexel Co., Ltd 101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro Jungwon-gu Seongnam-si, KR 13207 |
| Contact | Sung Kyu Hur |
| Correspondent | Milan George Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, PA 19403 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-08 |
| Decision Date | 2022-03-25 |