HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15— 510(k) K040381

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K040381 for HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15, Substantially Equivalent on 2004-05-12. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-02-17
Decision date: 2004-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.