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Sign in to claim this brandBack 2 Basics Direct, LLC
US
Last updated May 23, 2026
What Back 2 Basics Direct, LLC makes
Back 2 Basics Direct, LLC manufactures the eCarbon IBDs, an implantable device for internal fixation, and the Dymaxeon Spine System, a spinal fixation and stabilization solution designed for surgical use.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Back 2 Basics Direct, LLC manufacture?
Back 2 Basics Direct, LLC produces two primary types of medical devices: the eCarbon IBDs, which are implantable devices used for internal bone fixation, and the Dymaxeon Spine System, a spinal fixation and stabilization solution designed for surgical procedures. These devices are intended to support structural integrity in orthopedic and spinal applications.
Where is Back 2 Basics Direct, LLC based?
The company is headquartered in the United States. This location aligns with its regulatory obligations under U.S. medical device laws, including compliance with FDA requirements for device classification and clearance pathways.
How are Back 2 Basics Direct, LLC’s devices classified under FDA regulations?
All devices manufactured by Back 2 Basics Direct, LLC are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The 510(k) pathway is used to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Back 2 Basics Direct, LLC’s devices?
Back 2 Basics Direct, LLC’s devices are listed in the FDA’s 510(k) database. This registry tracks devices that have undergone the 510(k) premarket notification process, ensuring they meet FDA requirements for safety and performance before commercial distribution. The listing confirms the device’s regulatory pathway but does not imply approval—only that it has been reviewed for compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (552)
Page 8 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dymaxeon® | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Unknown |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Unknown |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Unknown |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Unknown |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Unknown |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Active |
| Dymaxeon® | 06.0 | FDA UDI | Class II | Unknown |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon® | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
| Dymaxeon | 05.5 | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Back 2 Basics Direct, LLC has one FDA recall record initiated on 2018-06-29, which is listed with a terminated status. The recall was due to mislabeled packages, where items labeled as containing 110mm rods may have contained 100mm rods instead.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 29, 2018 | Z-2881-2018 | — | terminated | Packages labeled as containing 110mm rods may contain 100mm rods. |