# Novabone Products, LLC

- Location (FDA's records): Alachua, FL
- FDA decisions: 30 (2002–2024): 30 510(k) clearances
- Product codes: MQV (19), LYC (9), KGN (2)
- 510(k) review time since 2016: median 55 days, against 90 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 106 (67 its own); citations of its devices by later devices: 123 (67 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Usbiomaterials Corp.: 25 (https://510kreport.com/company/usbiomaterials)
- Exactech, Inc.: 2 (https://510kreport.com/company/exactech)
- Osteotech, Inc.: 2 (https://510kreport.com/company/osteotech)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Interpore Intl.: 1 (https://510kreport.com/company/interpore-intl)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Firms that cite its devices most
- Prosidyan, Inc.: 14 (https://510kreport.com/company/prosidyan)
- Inion, Ltd.: 5 (https://510kreport.com/company/inion)
- SurGenTec, LLC: 4 (https://510kreport.com/company/surgentec)
- Vivoxid, Ltd.: 3 (https://510kreport.com/company/vivoxid)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Orthovita, Inc.: 3 (https://510kreport.com/company/orthovita)
- Biostructures, LLC: 2 (https://510kreport.com/company/biostructures)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)

## Its most-cited devices
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), cited by 14
- K080009: Novabone Putty- Bioactive Synthetic Graft (2008), cited by 13
- K021336: Novabone-Resorbable Bone Graft Substitute (2002), cited by 13
- K040278: Perioglas-Bioglass Bone Graft Substitute (2004), cited by 12
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft (2010), cited by 8
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), cited by 8

## Recent decisions
- K242299: NovaBone Putty - Synthetic Bioactive Bone Graft (Sep 25, 2024)
- K240404: NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (Mar 5, 2024)
- K220498: NovoGen Wound Matrix (Jun 9, 2023)
- K163310: NovaBone IRM (Jan 18, 2017)
- K152071: NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) (Aug 26, 2015)
- K142712: Dental Collagen Wound Dressing (Nova Tape and NovaPlug) (Jan 8, 2015)
- K141207: Novabone Bioactive Strip (Oct 31, 2014)
- K140946: Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite (Aug 22, 2014)

Source page: https://510kreport.com/company/novabone-products