Biogennix
Biogennix appears in FDA public data with 0 recalls, 9 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 8, 2024 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Apr 30, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 8, 2024 | Irvine, CA | Devices | No Action Indicated (NAI) | 3008773560 |
| Jul 29, 2016 | Irvine, CA | Devices | No Action Indicated (NAI) | 3008773560 |
| Apr 18, 2012 | Irvine, CA | Devices | No Action Indicated (NAI) | 3008773560 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K240621 | Morpheus® Moldable; Agilon® Moldable | Apr 30, 2024 |
| K193487 | Agilon Strip | Mar 30, 2020 |
| K193168 | Agilon Moldable | Feb 13, 2020 |
| K190371 | Morpheus-C | Aug 9, 2019 |
| K181337 | Sypher Spacer System | Sep 18, 2018 |
| K141798 | SYPHER SPACER SYSTEM | Feb 19, 2015 |
| K142828 | osteoSPAN Morpheus | Jan 15, 2015 |
| K132377 | OSTEOSPAN MORPHEUS | May 20, 2014 |
| K093342 | BIOGENNIX RPC | Jul 29, 2010 |