NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003— 510(k) K071714

Substantially Equivalent

Orthosoft, Inc.

FDA 510(k) clearance K071714 for NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003, Substantially Equivalent on 2007-07-20. Applicant: Orthosoft, Inc..

Clearance details

Applicant: Orthosoft, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2007-06-22
Decision date: 2007-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.