Data / Medical devices / United States / Pur Biologics, LLC
Pur Biologics, LLC: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Pur Biologics, LLC is registered with the FDA (registration 3010770940) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010770940
- Address
- 16520 Bake Pkwy Ste 105, Irvine, CA, United States, 92618
- Owner or operator
- PUR Biologics, LLC (10046283)
- Roles
- Repackager or relabeler
- First device listed
- October 24, 2022
- Registered through
- 2026
- Brand names listed
- PUR Bioglass Bridge, PUR basic, PUR core, PUR crystals, PUR fuze, PUR pillars
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| July 6, 2006 | K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 6, 2006. 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.