SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525— 510(k) K993074

Substantially Equivalent

Bionx Implants, Ltd.

FDA 510(k) clearance K993074 for SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525, Substantially Equivalent on 1999-12-10. Applicant: Bionx Implants, Ltd..

Clearance details

Applicant: Bionx Implants, Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1999-09-14
Decision date: 1999-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

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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.