LANX DEFORMITY SYSTEM— 510(k) K071633

Substantially Equivalent

Lanx, LLC

FDA 510(k) clearance K071633 for LANX DEFORMITY SYSTEM, Substantially Equivalent on 2007-08-15. Applicant: Lanx, LLC.

Clearance details

Applicant: Lanx, LLC
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2007-06-14
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.