QuikFix External Fixator: Knee-Spanning Pack— 510(k) K260112

Substantially Equivalent

Stabiliz Orthopaedics, Inc.

FDA 510(k) clearance K260112 for QuikFix External Fixator: Knee-Spanning Pack, Substantially Equivalent on 2026-03-23. Applicant: Stabiliz Orthopaedics, Inc..

Clearance details

Applicant: Stabiliz Orthopaedics, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2026-01-14
Decision date: 2026-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, 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.