APEX INTRAMEDULLARY NAIL SYSTEM— 510(k) K020562

Substantially Equivalent

Magly Orthopedics, LLC

FDA 510(k) clearance K020562 for APEX INTRAMEDULLARY NAIL SYSTEM, Substantially Equivalent on 2002-05-16. Applicant: Magly Orthopedics, LLC.

Clearance details

Applicant: Magly Orthopedics, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2002-02-20
Decision date: 2002-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.