TITANIUM ALLOY SONGER CABLE SYSTEM— 510(k) K920201

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..

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code JDQ
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

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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.