ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)— 510(k) K141078

Clearance details

Applicant

Orthofix Srl

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2014-04-25

Decision date

2014-09-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, NC, US

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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 →