OptiVu ROSA MxR— 510(k) K220733

Name: FDA 510(k) clearance K220733
Creator: U.S. Food and Drug Administration
Published: 2022-07-29

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K220733 for OptiVu ROSA MxR, Substantially Equivalent on 2022-07-29. Applicant: Orthosoft Inc (D/B/A Zimmer Cas). Device class: 2.

Clearance details

Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2022-03-14
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Orthosoft Inc (D/B/A Zimmer Cas)

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K261510 — Signature ONE System2026-06-04
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K251314 — Rosa® Knee System2025-11-13
K242864 — ROSA® Knee System2024-10-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.