ARTHREX PUSHLOCK ANCHORS— 510(k) K101679

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K101679 for ARTHREX PUSHLOCK ANCHORS, Substantially Equivalent on 2010-10-22. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2010-06-15
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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.