TITANIUM SONGER CABLE SYSTEM— 510(k) K925812

Name: FDA 510(k) clearance K925812
Creator: U.S. Food and Drug Administration
Published: 1993-03-24

Substantially Equivalent

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K925812 for TITANIUM SONGER CABLE SYSTEM, Substantially Equivalent on 1993-03-24. Applicant: Sofamor Danek Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1992-11-12
Decision date: 1993-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K932029 — TSRH SPINAL SCREWS1995-01-20
K922486 — DANEK TISSUE CUTTING AND REMOVAL SYSTEM1993-10-12
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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.