CONSTRUX EXTERNAL FIXATION DEVICE— 510(k) K111376

Clearance details

Applicant

Ebi, LLC

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2011-05-16

Decision date

2011-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, 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 →

• Z-1741-2015 — Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modalityClass II·Terminated·Biomet, Inc.·20150501

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111376.