DANEK WRIST FIXATOR— 510(k) K891066

Name: FDA 510(k) clearance K891066
Creator: U.S. Food and Drug Administration
Published: 1989-08-28

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K891066 for DANEK WRIST FIXATOR, Substantially Equivalent on 1989-08-28. Applicant: Danek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1989-03-01
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM1999-12-15
K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR1999-05-28
K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM1999-03-10

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.