BioPoly Radial Head Implant— 510(k) K233592
Substantially EquivalentBioPoly, LLC
FDA 510(k) clearance K233592 for BioPoly Radial Head Implant, Substantially Equivalent on 2024-03-13. Applicant: BioPoly, LLC.
Clearance details
- Applicant
- BioPoly, LLC
- Product code
- Code KWI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Wayne, IN, US
Adverse events under product code KWI
product code KWI- Injury
- 490
- Total
- 490
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.