MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM— 510(k) K021579

Substantially Equivalent

Magly Orthopedics, LLC

FDA 510(k) clearance K021579 for MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM, Substantially Equivalent on 2002-08-09. Applicant: Magly Orthopedics, LLC.

Clearance details

Applicant: Magly Orthopedics, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2002-05-14
Decision date: 2002-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.