BONE GRAFT WASHER, MODEL 9090114 - 9090118— 510(k) K994122

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K994122 for BONE GRAFT WASHER, MODEL 9090114 - 9090118, Substantially Equivalent on 2000-02-18. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1999-12-07
Decision date: 2000-02-18
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.