DYNA LOCKING IM NAIL— 510(k) K092771

Substantially Equivalent

U&I Corp.

FDA 510(k) clearance K092771 for DYNA LOCKING IM NAIL, Substantially Equivalent on 2009-12-02. Applicant: U&I Corp..

Clearance details

Applicant: U&I Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2009-09-09
Decision date: 2009-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijungbu, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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.