FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)— 510(k) K031401

Substantially Equivalent

Disco-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K031401 for FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS), Substantially Equivalent on 2003-08-06. Applicant: Disco-O-Tech Medical Technologies, Ltd..

Clearance details

Applicant: Disco-O-Tech Medical Technologies, Ltd.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-05-05
Decision date: 2003-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzlia, IL

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.