IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET— 510(k) K020221

Substantially Equivalent

Biomet Orthopedics, Inc.

FDA 510(k) clearance K020221 for IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET, Substantially Equivalent on 2002-04-02. Applicant: Biomet Orthopedics, Inc..

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2002-01-22
Decision date: 2002-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.