ROSA Hip System— 510(k) K210998

Substantially Equivalent

Orthosoft D/B/A Zimmer Cas

FDA 510(k) clearance K210998 for ROSA Hip System, Substantially Equivalent on 2021-08-17. Applicant: Orthosoft D/B/A Zimmer Cas.

Clearance details

Applicant: Orthosoft D/B/A Zimmer Cas
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-04-02
Decision date: 2021-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.