Arthrex Corkscrew FT— 510(k) K173788

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K173788 for Arthrex Corkscrew FT, Substantially Equivalent on 2018-03-01. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2017-12-14
Decision date: 2018-03-01
Decision: Substantially Equivalent
Clearance type: Special
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.