510(k) Report

FDA applicant

Novabone Products, LLC

Alachua, FL30 decisions2002–20240 recalls

FDA records 30 decisions for Novabone Products, LLC (Alachua, FL) from 2002 to 2024: 30 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Since 2016 its 510(k)s took a median of 55 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 106 predicates, 67 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, orthopedic panel, where it files most

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

FDA decisions per year

2in 2024

2007: 22008: 22009: 22010: 22011: 42014: 22015: 22017: 12023: 12024: 2
2007high 4 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novabone Products, 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?

  • MQVFiller, Bone Void, Calcium Compound19decisions
  • LYCBone Grafting Material, Synthetic9decisions
  • KGNWound Dressing With Animal-Derived Material (S)2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 55 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 106 predicates; 67 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 123 times; 67 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.

  • K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 200614cite it
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 200813cite it
  • K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 200213cite it
  • K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 200412cite it
  • K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 20108cite it
  • K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 20088cite it

What has FDA decided for it lately?

  • K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC · 2024
  • K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC · 2024
  • K220498NovoGen Wound MatrixNovabone Products, LLC · 2023
  • K163310NovaBone IRMNovabone Products, LLC · 2017
  • K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)Novabone Products, LLC · 2015
  • K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)Novabone Products, LLC · 2015
  • K141207Novabone Bioactive StripNovabone Products, LLC · 2014
  • K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC · 2014

All 30 as Novabone Products, LLC →