510(k) K222964— BioPoly Lesser Toe Hemiarthroplasty Implant

Substantially Equivalent

BioPoly, LLC

Clearance details

Applicant: BioPoly, LLC
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2022-09-27
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.