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 | K192930 |
| 510k Number | K192930 |
| 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 | Lou Keppler |
| Correspondent | Karen E Warden BackRoads Consulting 12520 Heath Road Chesterland, OH 44026 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2020-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B562090681NS0 | K192930 | 000 |