ERS RADIAL HEAD REPLACEMENT— 510(k) K000658

Name: FDA 510(k) clearance K000658
Creator: U.S. Food and Drug Administration
Published: 2000-05-11

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K000658 for ERS RADIAL HEAD REPLACEMENT, Substantially Equivalent on 2000-05-11. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2000-02-28
Decision date: 2000-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17

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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.