ARTHREX PIP DART— 510(k) K141577

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K141577 for ARTHREX PIP DART, Substantially Equivalent on 2014-07-18. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2014-06-13
Decision date: 2014-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.