BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B— 510(k) K983843

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K983843 for BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B, Substantially Equivalent on 1999-03-12. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1998-10-30
Decision date: 1999-03-12
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.