BioPoly Great Toe Hemiarthroplasty Implant— 510(k) K203634

Substantially Equivalent

BioPoly, LLC

FDA 510(k) clearance K203634 for BioPoly Great Toe Hemiarthroplasty Implant, Substantially Equivalent on 2021-02-02. Applicant: BioPoly, LLC.

Clearance details

Applicant: BioPoly, LLC
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2020-12-11
Decision date: 2021-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

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.