ACL TIGHTROPE— 510(k) K100652

Name: FDA 510(k) clearance K100652
Creator: U.S. Food and Drug Administration
Published: 2010-06-23

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K100652 for ACL TIGHTROPE, Substantially Equivalent on 2010-06-23. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2010-03-08
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.