TITANIUM ALLOY SONGER CABLE SYSTEM— 510(k) K920201

Name: FDA 510(k) clearance K920201
Creator: U.S. Food and Drug Administration
Published: 1992-04-08

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K920201 for TITANIUM ALLOY SONGER CABLE SYSTEM, Substantially Equivalent for Some Indications on 1992-04-08. 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: 1992-01-15
Decision date: 1992-04-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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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.