Arthrex Small External Fixation System— 510(k) K232897

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K232897 for Arthrex Small External Fixation System, Substantially Equivalent on 2023-10-18. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2023-09-18
Decision date: 2023-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.