DYNA LOCKING ANKLE NAIL— 510(k) K120419

Substantially Equivalent

U&I Corp.

FDA 510(k) clearance K120419 for DYNA LOCKING ANKLE NAIL, Substantially Equivalent on 2012-05-21. Applicant: U&I Corp..

Clearance details

Applicant: U&I Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2012-02-10
Decision date: 2012-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijeongbu-Si, Gyeonggi-Do, KR

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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.