Avenger Radial Head System— 510(k) K212872

Name: FDA 510(k) clearance K212872
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Substantially Equivalent

In2bones USA, LLC

FDA 510(k) clearance K212872 for Avenger Radial Head System, Substantially Equivalent on 2021-12-17. Applicant: In2bones USA, LLC. Device class: 2.

Clearance details

Applicant: In2bones USA, LLC
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2021-09-09
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K192754 — Avenger Radial Head System2020-01-07

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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.