Avenger Radial Head System— 510(k) K192754

Substantially Equivalent

In2bones USA, LLC

FDA 510(k) clearance K192754 for Avenger Radial Head System, Substantially Equivalent on 2020-01-07. Applicant: In2bones USA, LLC.

Clearance details

Applicant: In2bones USA, LLC
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2019-09-30
Decision date: 2020-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.