ONE Planner Hip— 510(k) K210653

Substantially Equivalent

Orthosoft D/B/A Zimmer Cas

FDA 510(k) clearance K210653 for ONE Planner Hip, Substantially Equivalent on 2021-07-07. 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: 2021-03-04
Decision date: 2021-07-07
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.