OptiVu ROSA® MxR— 510(k) K230567

Name: FDA 510(k) clearance K230567
Creator: U.S. Food and Drug Administration
Published: 2023-06-13

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K230567 for OptiVu ROSA® MxR, Substantially Equivalent on 2023-06-13. 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: 2023-03-01
Decision date: 2023-06-13
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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K242864 — ROSA® Knee System2024-10-18

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