SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION— 510(k) K940744

Substantially Equivalent for Some Indications

Sofamor Co.

FDA 510(k) clearance K940744 for SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION, Substantially Equivalent for Some Indications on 1996-01-30. Applicant: Sofamor Co..

Clearance details

Applicant: Sofamor Co.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1994-02-17
Decision date: 1996-01-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: France, FR

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.