ELLIS EXTERNAL MINI-FIXATOR SYSTEM— 510(k) K964458

Name: FDA 510(k) clearance K964458
Creator: U.S. Food and Drug Administration
Published: 1996-12-09

Substantially Equivalent

Link America, Inc.

FDA 510(k) clearance K964458 for ELLIS EXTERNAL MINI-FIXATOR SYSTEM, Substantially Equivalent on 1996-12-09. Applicant: Link America, Inc.. Device class: 2.

Clearance details

Applicant: Link America, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1996-11-07
Decision date: 1996-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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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.

Clearance details

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Adverse events under product code KTT