510(k) Report

FDA applicant

Novaspine, LLC

Elmsford, NY3 decisions2005–20060 recalls

FDA records 3 decisions for Novaspine, LLC (Elmsford, NY) from 2005 to 2006: 3 510(k) clearances. Most are in product codes JDK (Prosthesis, Hip, Cement Restrictor) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 12 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Novaspine, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novaspine, 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?

  • JDKProsthesis, Hip, Cement Restrictor1decision
  • OMPNegative Pressure Wound Therapy Powered Suction Pump1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 20063cite it
  • K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 20063cite it

What has FDA decided for it lately?

  • K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
  • K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 2006
  • K051607Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005

All 3 as Novaspine, LLC →