ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART— 510(k) K082999

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K082999 for ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART, Substantially Equivalent on 2008-12-30. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2008-10-08
Decision date: 2008-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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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.