ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K993855

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K993855 for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 1999-12-15. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1999-11-15
Decision date: 1999-12-15
Decision: Substantially Equivalent
Clearance type: Special
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.