Biogennix, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biogennix, LLC” (first 2010, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 104 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 293 |
| 2015 | 2 | 169 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 120 |
| 2019 | 1 | 175 |
| 2020 | 2 | 97 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 56 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biogennix, LLC took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Biogennix, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240621 | Morpheus® Moldable; Agilon® Moldable | MQV | 2024-04-30 | 56 |
| K193487 | Agilon Strip | MQV | 2020-03-30 | 104 |
| K193168 | Agilon Moldable | MQV | 2020-02-13 | 90 |
| K190371 | Morpheus-C | MQV | 2019-08-09 | 175 |
| K181337 | Sypher Spacer System | MAX | 2018-09-18 | 120 |
| K141798 | SYPHER SPACER SYSTEM | OVD | 2015-02-19 | 231 |
| K142828 | osteoSPAN Morpheus | MQV | 2015-01-15 | 107 |
| K132377 | OSTEOSPAN MORPHEUS | MQV | 2014-05-20 | 293 |
| K093342 | BIOGENNIX RPC | MQV | 2010-07-29 | 276 |
Recalls
openFDA lists no recalls under a recalling firm named Biogennix, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biogennix, LLC?
FDA lists 9 510(k) clearances under the applicant name “Biogennix, LLC” (first 2010, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biogennix, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biogennix, LLC is 120 days. Since 2017: 104 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biogennix, LLC?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 7); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 1).
Next steps
- See all 9 Biogennix, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQV, Biogennix, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.