MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K090316

Substantially Equivalent

Lanx, Inc.

FDA 510(k) clearance K090316 for MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2009-04-07. Applicant: Lanx, Inc..

Clearance details

Applicant: Lanx, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2009-02-09
Decision date: 2009-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomfield, CO, 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.