Back 2 Basics Direct, LLC
Independence, OH, US
Back 2 Basics Direct, LLC appears in FDA device records in Independence, OH. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Back 2 Basics Direct, LLC between 2015 and 2020. The busiest year on record is 2015, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192930 | Dymaxeon Spine System | NKB | Substantially Equivalent | |
| K191537 | eCarbon IBDs | ODP | Substantially Equivalent | |
| K170989 | Dymaxeon Spine System | NKB | Substantially Equivalent | |
| K150184 | Dymaxeon Spine System | NKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2881-2018 | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). | Packages labeled as containing 110mm rods may contain 100mm rods. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain