Novabone Products, LLC
Alachua, FL, US
NOVABONE PRODUCTS, LLC appears in FDA device records in Alachua, FL. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Novabone Products, LLC between 2002 and 2024. The busiest year on record is 2006, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 4 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | MQV | Substantially Equivalent | |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | MQV | Substantially Equivalent | |
| K220498 | NovoGen Wound Matrix | KGN | Substantially Equivalent | |
| K163310 | NovaBone IRM | MQV | Substantially Equivalent | |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) | MQV | Substantially Equivalent | |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | KGN | Substantially Equivalent | |
| K141207 | NOVABONE BIOACTIVE STRIP | MQV | Substantially Equivalent | |
| K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE | MQV | Substantially Equivalent | |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | |
| K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | |
| K110925 | NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT | MQV | Substantially Equivalent | |
| K110368 | NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | |
| K101860 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | |
| K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | |
| K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | |
| K090731 | NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD | MQV | Substantially Equivalent | |
| K082672 | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | MQV | Substantially Equivalent | |
| K080009 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT | MQV | Substantially Equivalent | |
| K063596 | PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL | LYC | Substantially Equivalent | |
| K063549 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | LYC | Substantially Equivalent | |
| K060728 | NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT | MQV | Substantially Equivalent | |
| K060432 | NOVABONE POROUS-BONE GRAFT SCAFFOLD | MQV | Substantially Equivalent | |
| K051617 | NOVABONE PUTTY - RESORBABLE BONE VOID FILLER | MQV | Substantially Equivalent | |
| K053387 | PERIOGLAS BONE GRAFT PARTICULATE | LYC | Substantially Equivalent | |
| K052494 | NOVABONE-BIOACTIVE SYNTHETIC GRAFT | MQV | Substantially Equivalent | |
| K041613 | NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K033994 | NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | |
| K040278 | PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | |
| K031073 | PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | |
| K021336 | NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003768919 | 3003768919 | NOVABONE PRODUCTS, LLC | 13510 NW US Highway 441, ALACHUA, FL 32615 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain