The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Dvx Spine System.
| Device ID | K080876 |
| 510k Number | K080876 |
| Device Name: | DVX SPINE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-06-04 |
| Summary: | summary |