LINK(TM) External Fixator— 510(k) K240049

Name: FDA 510(k) clearance K240049
Creator: U.S. Food and Drug Administration
Published: 2024-05-29

Substantially Equivalent

Metric Medical Devices, Inc.

FDA 510(k) clearance K240049 for LINK(TM) External Fixator, Substantially Equivalent on 2024-05-29. Applicant: Metric Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Metric Medical Devices, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-01-08
Decision date: 2024-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helotes, TX, US

Download summary PDF View on FDA.gov ↗

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K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

More clearances from Metric Medical Devices, Inc.

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K152627 — IFS Fixation Scaffold System2016-01-13
K123363 — SUPER STAPLE(TM) CLASSIC2013-01-03

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.