510(k) Report

FDA applicant

Back 2 Basics Direct, LLC

Independence, OH4 decisions2015–20201 recall

FDA records 4 decisions for Back 2 Basics Direct, LLC (Independence, OH) from 2015 to 2020: 4 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Back 2 Basics Direct, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12017: 12019: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2015high 1 (2018) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Back 2 Basics Direct, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Back 2 Basics Direct, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 69 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 20153cite it
  • K191537eCarbon IBDsBack 2 Basics Direct, LLC · 20192cite it
  • K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 20171cites it
  • K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 20201cites it

What has FDA decided for it lately?

  • K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
  • K191537eCarbon IBDsBack 2 Basics Direct, LLC · 2019
  • K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
  • K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 20151 recall

All 4 as Back 2 Basics Direct, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150184Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage…Jun 29, 2018Class II

Other applicant names beginning “Back”

FDA records each applicant name separately; these may or may not be the same firm.

Back IN Action, Inc. 2Back-On-Track, Inc. 1Back Rite 1