The following data is part of a premarket notification filed by Back 2 Basics Direct, Llc with the FDA for Dymaxeon Spine System.
| Device ID | K170989 |
| 510k Number | K170989 |
| Device Name: | Dymaxeon Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Back 2 Basics Direct, LLC 6701 Rockside Road, Suite 200 Independence, OH 44131 |
| Contact | Mitchell Bass |
| Correspondent | Melissa Spang JALEX Medical 30311 Clemens Road Suite #3D Westlake, OH 44145 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-05-22 |
| Summary: | summary |