2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445— 510(k) K031981

Substantially Equivalent

Linvatec Biomaterials, Ltd.

FDA 510(k) clearance K031981 for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445, Substantially Equivalent on 2003-07-25. Applicant: Linvatec Biomaterials, Ltd..

Clearance details

Applicant: Linvatec Biomaterials, Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2003-06-26
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.