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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809155854665 | K080876 | 000 |
| 08809155852241 | K080876 | 000 |
| 08809155852234 | K080876 | 000 |
| 08809155852227 | K080876 | 000 |
| 08809155852203 | K080876 | 000 |
| 08809155852197 | K080876 | 000 |
| 08809155852180 | K080876 | 000 |
| 08809155852173 | K080876 | 000 |
| 08809155852166 | K080876 | 000 |
| 08809155852159 | K080876 | 000 |
| 08809155852135 | K080876 | 000 |
| 08809155852128 | K080876 | 000 |
| 08809155852111 | K080876 | 000 |
| 08809155852104 | K080876 | 000 |
| 08809155852098 | K080876 | 000 |
| 08809155852258 | K080876 | 000 |
| 08809155852265 | K080876 | 000 |
| 08809155854658 | K080876 | 000 |
| 08809155854641 | K080876 | 000 |
| 08809155854634 | K080876 | 000 |
| 08809155854627 | K080876 | 000 |
| 08809155854610 | K080876 | 000 |
| 08809155854603 | K080876 | 000 |
| 08809155854597 | K080876 | 000 |
| 08809155852593 | K080876 | 000 |
| 08809155852586 | K080876 | 000 |
| 08809155852579 | K080876 | 000 |
| 08809155852562 | K080876 | 000 |
| 08809155852555 | K080876 | 000 |
| 08809155852289 | K080876 | 000 |
| 08809155852272 | K080876 | 000 |
| 08809155852081 | K080876 | 000 |