Data / Medical devices / United States / Biogennix, LLC
Biogennix, LLC: FDA-registered device maker in Irvine, CA, United States, 7 510(k) clearances
Biogennix, LLC is registered with the FDA (registration 3008773560) in Irvine, CA, United States. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 30, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008773560
- Address
- 18009 Sky Park Cir Ste K, Irvine, CA, United States, 92614
- Owner or operator
- Biogennix, LLC (10030571)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 28, 2010
- Registered through
- 2026
- Brand names listed
- Agilon, Agilon Moldable, Agilon Strip, Angulating Awl with Handle, Angulating Screwdriver with Handle, Articulating Awl Guide, Bullet Distractors with Bullet Distractor Inserter, Cover Plate Driver with Torque Handle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2020 | K193487 | Agilon Strip | MQV | Substantially Equivalent | Biogennix, LLC | accessdata.fda.gov |
| February 13, 2020 | K193168 | Agilon Moldable | MQV | Substantially Equivalent | Biogennix, LLC | accessdata.fda.gov |
| August 9, 2019 | K190371 | Morpheus-C | MQV | Substantially Equivalent | Biogennix, LLC | accessdata.fda.gov |
| June 12, 2019 | K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | KNW | Substantially Equivalent | Ranfac Corporation | accessdata.fda.gov |
| February 19, 2015 | K141798 | SYPHER SPACER SYSTEM | OVD | Substantially Equivalent | Biogennix, LLC | accessdata.fda.gov |
| January 15, 2015 | K142828 | osteoSPAN Morpheus | MQV | Substantially Equivalent | Biogennix | accessdata.fda.gov |
| July 29, 2010 | K093342 | BIOGENNIX RPC | MQV | Substantially Equivalent | Biogennix, LLC | accessdata.fda.gov |
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Updated March 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.