Novabone Products, LLC: FDA clearances and approvals
Novabone Products, LLC has 30 FDA 510(k) clearances (first 2002, latest 2024), across 3 product codes in 3 review panels. Median 510(k) review time: 71 days. Since 2017 its median was 55 days, against 124 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 152 |
| 2015 | 2 | 69 |
| 2016 | 0 | — |
| 2017 | 1 | 56 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 472 |
| 2024 | 2 | 40 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Novabone Products, LLC's cleared 510(k)s took a median 55 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 19 | 19 |
| LYC | Bone Grafting Material, Synthetic | 9 | 9 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
Review panels
- Orthopedic (19)
- Dental (9)
- General and Plastic Surgery (2)
Most recent Novabone Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | MQV | 2024-09-25 | 54 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | MQV | 2024-03-05 | 25 |
| K220498 | NovoGen Wound Matrix | KGN | 2023-06-09 | 472 |
| K163310 | NovaBone IRM | MQV | 2017-01-18 | 56 |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) | MQV | 2015-08-26 | 30 |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | KGN | 2015-01-08 | 108 |
| K141207 | NOVABONE BIOACTIVE STRIP | MQV | 2014-10-31 | 175 |
| K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE | MQV | 2014-08-22 | 130 |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | LYC | 2011-12-16 | 115 |
| K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | MQV | 2011-10-14 | 21 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Novabone Products, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Novabone Products, LLC have?
Novabone Products, LLC has 30 FDA 510(k) clearances (first 2002, latest 2024), across 3 product codes in 3 review panels.
How long does FDA take to clear Novabone Products, LLC's 510(k)s?
The median time from FDA receipt to decision across Novabone Products, LLC's cleared 510(k)s is 71 days. Since 2017: 55 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Novabone Products, LLC make?
Its most frequent FDA product codes are MQV (Filler, Bone Void, Calcium Compound, 19); LYC (Bone Grafting Material, Synthetic, 9); KGN (Wound Dressing With Animal-Derived Material(S), 2).
Has Novabone Products, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Novabone Products, LLC. Related entities may recall under other names.
Next steps
- See all 30 Novabone Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQV, Novabone Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.