Signature ONE System— 510(k) K190595

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K190595 for Signature ONE System, Substantially Equivalent on 2019-06-05. Applicant: Orthosoft Inc (D/B/A Zimmer Cas).

Clearance details

Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2019-03-07
Decision date: 2019-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.