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OptiVu ROSA MxR

by Orthosoft Inc. (d/b/a) Zimmer CAS

510(k) K230567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230567 Date13 Jun 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
SBF
FDA applicant
Orthosoft Inc (D/B/A Zimmer Cas)
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OptiVu ROSA MxR is an Orthopedic Augmented Reality device designed for surgical navigation and planning. It integrates augmented reality technology to provide real-time visualization of surgical workflows, enhancing precision during orthopedic procedures, particularly in neurology-related applications.

This device is supplied as a reusable system for use in sterile surgical environments, with MRI safety considerations as outlined in its specifications. It operates within Class 2 regulatory classification under FDA 510(k) clearance (K230567), adhering to traditional review standards. The device is intended for use in clinical settings where augmented reality-assisted orthopedic interventions are performed.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the OptiVu ROSA MxR device used for?

    The OptiVu ROSA MxR is an orthopedic augmented reality device designed for surgical navigation and planning, providing real-time visualization of surgical workflows to enhance precision during orthopedic procedures, particularly in neurology-related applications.

  • How is the OptiVu ROSA MxR supplied and what are its sterility requirements?

    The device is supplied as a reusable system for use in sterile surgical environments, with MRI safety considerations as outlined in its specifications. It is designed to be used in clinical settings where augmented reality-assisted orthopedic interventions are performed.

  • What is the regulatory classification and clearance status of the OptiVu ROSA MxR?

    The OptiVu ROSA MxR operates within Class 2 regulatory classification under FDA 510(k) clearance (K230567), adhering to traditional review standards. It was found to be substantially equivalent through the traditional review process.

  • What are the storage requirements for the OptiVu ROSA MxR?

    The device data does not specify particular storage requirements beyond its intended use in sterile surgical environments. Users should follow the manufacturer's guidelines for proper storage to maintain device functionality.