Data / Medical devices / United States / Biopoly, LLC
Biopoly, LLC: FDA-registered device maker in Fort Wayne, IN, United States, 3 510(k) clearances
Biopoly, LLC is registered with the FDA (registration 3008108789) in Fort Wayne, IN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008108789
- Address
- 7136 Gettysburg Pike, Fort Wayne, IN, United States, 46804
- Owner or operator
- BioPoly, LLC (10041050)
- Roles
- Manufacturer
- First device listed
- October 19, 2021
- Registered through
- 2026
- Brand names listed
- BioPoly® Great Toe Hemiarthroplasty Implant, BioPoly® Lesser Toe Hemiarthroplasty Implant, BioPoly® Radial Head Implant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 13, 2024 | K233592 | BioPoly Radial Head Implant | KWI | Substantially Equivalent | BioPoly, LLC | accessdata.fda.gov |
| November 22, 2022 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | KWD | Substantially Equivalent | BioPoly, LLC | accessdata.fda.gov |
| February 2, 2021 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | KWD | Substantially Equivalent | BioPoly, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Toe, Hemi-, Phalangeal
- All makers of Prosthesis, Elbow, Hemi-, Radial, Polymer
Updated March 13, 2024. 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.