# Back 2 Basics Direct, LLC

- Location (FDA's records): Independence, OH
- FDA decisions: 4 (2015–2020): 4 510(k) clearances
- Product codes: NKB (3), ODP (1)
- 510(k) review time since 2016: median 108 days, against 69 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 16 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B2b Spine Pty, Ltd.: 2 (https://510kreport.com/company/b2b-spine)
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)
- Co-Ligne AG: 1 (https://510kreport.com/company/co-ligne)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Blackstone Medical, Inc.: 1 (https://510kreport.com/company/blackstone-medical)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)

## Firms that cite its devices most
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)
- Acro Composites, LLC: 1 (https://510kreport.com/company/acro-composites)
- CarboFix Orthopedics, Ltd.: 1 (https://510kreport.com/company/carbofix-orthopedics)
- Carbofix Orthpedics, Ltd.: 1 (https://510kreport.com/company/carbofix-orthpedics)

## Its most-cited devices
- K150184: Dymaxeon Spine System (2015), cited by 3
- K191537: eCarbon IBDs (2019), cited by 2
- K170989: Dymaxeon Spine System (2017), cited by 1
- K192930: Dymaxeon Spine System (2020), cited by 1

## Recent decisions
- K192930: Dymaxeon Spine System (May 12, 2020)
- K191537: eCarbon IBDs (Sep 26, 2019)
- K170989: Dymaxeon Spine System (May 22, 2017)
- K150184: Dymaxeon Spine System (Jun 15, 2015)

Source page: https://510kreport.com/company/back-2-basics-direct