POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)— 510(k) K071905

Substantially Equivalent

Lanx, LLC

FDA 510(k) clearance K071905 for POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS), Substantially Equivalent on 2007-12-28. Applicant: Lanx, LLC.

Clearance details

Applicant: Lanx, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2007-07-10
Decision date: 2007-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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.