The following data is part of a premarket notification filed by Back 2 Basics Direct, Llc with the FDA for Ecarbon Ibds.
| Device ID | K191537 |
| 510k Number | K191537 |
| Device Name: | ECarbon IBDs |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Back 2 Basics Direct, LLC 6701 Rockside Road, Suite 200 Independence, OH 44131 |
| Contact | Scot Miller |
| Correspondent | Karen E. Warden BackRoads Consulting 12520 Heath Road Chesterland, OH 44026 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-09-26 |
| Summary: | summary |