Data / Medical devices / United States / Novabone Products, LLC
Novabone Products, LLC: FDA-registered device maker in Alachua, FL, United States, 16 510(k) clearances
Novabone Products, LLC is registered with the FDA (registration 3003768919) in Alachua, FL, United States. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003768919
- Address
- 13510 NW US Highway 441, Alachua, FL, United States, 32615
- Owner or operator
- NOVABONE PRODUCTS, LLC (9052139)
- Roles
- Manufacturer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- BTB - BioActive Bone Graft Putty, Bioactive Strip, Bioactive Synthetic Bone Graft, Bioactive Synthetic Bone Graft Dental Morsels, Bioactive Synthetic Bone Graft Dental Putty Cartridges, Bioactive Synthetic Bone Graft IRM, Bioactive Synthetic Bone Graft MacroPor IRM, Bioactive Synthetic Bone Graft MacroPor-Si+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 5, 2024 | K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| June 9, 2023 | K220498 | NovoGen Wound Matrix | KGN | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| January 18, 2017 | K163310 | NovaBone IRM | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| January 8, 2015 | K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | KGN | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| October 31, 2014 | K141207 | NOVABONE BIOACTIVE STRIP | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| August 22, 2014 | K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| December 16, 2011 | K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| October 14, 2011 | K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| July 5, 2011 | K110925 | NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| September 1, 2010 | K101860 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| March 30, 2010 | K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| April 15, 2009 | K090731 | NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| December 9, 2008 | K082672 | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| May 6, 2008 | K080009 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| February 14, 2006 | K053387 | PERIOGLAS BONE GRAFT PARTICULATE | LYC | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
| November 3, 2005 | K052494 | NOVABONE-BIOACTIVE SYNTHETIC GRAFT | MQV | Substantially Equivalent | Novabone Products, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Bone Grafting Material, Synthetic
- All makers of Syringe, Restorative And Impression Material
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Tamp
Updated March 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.