ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K922087

Substantially Equivalent

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K922087 for ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 1992-11-06. Applicant: Sofamor Danek Mfg., Inc..

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1992-05-04
Decision date: 1992-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.