NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
FDA 510(k) K240404 · Novabone Products, LLC
510(k) numberK240404
Submission
- Device name
- NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
- Applicant
- Novabone Products, LLC
Alachua, FL, US - Received
- February 9, 2024
- Decision date
- March 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone GraftMQV · Traditional | 09/25/2024SE |
| K220498 | NovoGen Wound MatrixKGN · Traditional | 06/09/2023SE |
| K163310 | NovaBone IRMMQV · Traditional | 01/18/2017SE |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…MQV · Special | 08/26/2015SE |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug)KGN · Traditional | 01/08/2015SE |
| K141207 | Novabone Bioactive StripMQV · Traditional | 10/31/2014SE |
| K140946 | Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeMQV · Traditional | 08/22/2014SE |
| K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone GraftLYC · Traditional | 12/16/2011SE |
| K112773 | Novabne Putty Bioactive Synthetic Bone GraftMQV · Special | 10/14/2011SE |
| K110925 | Novabone Macropor-Si+ - Bioactive Bone GraftMQV · Traditional | 07/05/2011SE |
Questions and answers
When was NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) cleared by the FDA?
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (K240404) received a 510(k) decision of Substantially Equivalent on March 5, 2024, 25 days after the submission was received.
What is the product code of K240404?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.