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 | K150184 |
| 510k Number | K150184 |
| 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 | Scot Miller |
| Correspondent | Samuel Pollard MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-06-15 |
| Summary: | summary |