Double ENDOBUTTON Fixation Device— 510(k) K183232

Substantially Equivalent

Smith and Nephew, Inc.

FDA 510(k) clearance K183232 for Double ENDOBUTTON Fixation Device, Substantially Equivalent on 2019-03-12. Applicant: Smith and Nephew, Inc..

Clearance details

Applicant: Smith and Nephew, Inc.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2018-11-20
Decision date: 2019-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.