510(k) Report

FDA applicant

New Business Development, LLC

Woodstock, GA4 decisions2002–20070 recalls

FDA records 4 decisions for New Business Development, LLC (Woodstock, GA) from 2002 to 2007: 4 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and HAW (Neurological Stereotaxic Instrument). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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, neurology panel, where it files most

How often FDA has decided New Business Development, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — New Business Development, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New Business Development, 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?

  • MQPSpinal Vertebral Body Replacement Device1decision
  • HAWNeurological Stereotaxic Instrument1decision
  • GXIProbe, Radiofrequency Lesion1decision
  • JDKProsthesis, Hip, Cement Restrictor1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K072029Phenix Vertebral Body ReplacementNew Business Development, LLC · 20071cites it

What has FDA decided for it lately?

  • K072029Phenix Vertebral Body ReplacementNew Business Development, LLC · 2007
  • K050377NBD Head ScrewNew Business Development, LLC · 2005
  • K032196NBD Disposable RF CannulaeNew Business Development, LLC · 2003
  • K021788NBD Cement Restrictor DeviceNew Business Development, LLC · 2002

All 4 as New Business Development, LLC →