The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Balteum™ Lumbar Plate System.
| Device ID | K200846 |
| 510k Number | K200846 |
| Device Name: | Balteum™ 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 2900 Potshop Lane, Suite 200 Eagleville, 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 | 2020-03-31 |
| Decision Date | 2020-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800113999114 | K200846 | 000 |
| 08800039872386 | K200846 | 000 |
| 08800039872393 | K200846 | 000 |
| 08800039872409 | K200846 | 000 |
| 08800039872416 | K200846 | 000 |
| 08800039872423 | K200846 | 000 |
| 08800039874601 | K200846 | 000 |
| 08800039874625 | K200846 | 000 |
| 08800039874649 | K200846 | 000 |
| 08800039874663 | K200846 | 000 |
| 08800039874922 | K200846 | 000 |
| 08800039874946 | K200846 | 000 |
| 08800039874960 | K200846 | 000 |
| 08800039874984 | K200846 | 000 |
| 08800039887304 | K200846 | 000 |
| 08800039887311 | K200846 | 000 |
| 08800039887328 | K200846 | 000 |
| 08800039887335 | K200846 | 000 |
| 08800039872379 | K200846 | 000 |