Cleared Traditional

OptiVu? ROSA? MxR

K230567 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic
Jun 2023
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K230567 is an FDA 510(k) clearance for the OptiVu? ROSA? MxR, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on June 13, 2023, 104 days after receiving the submission on March 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K230567 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2023
Decision Date June 13, 2023
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code SBF — Orthopedic Augmented Reality
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As ?augmented Reality? Stereoscopic Images To Intraoperatively Augment The User?s Field Of View.