Cleared Traditional

K220554 - Caduceus S (FDA 510(k) Clearance)

K220554 · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Orthopedic device
Dec 2022
Decision
291d
Days
Class 2
Risk

K220554 is an FDA 510(k) clearance for the Caduceus S. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).

Submitted by Taiwan Main Orthopaedic Biotechnology Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on December 16, 2022, 291 days after receiving the submission on February 28, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. 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..

Submission Details

510(k) Number K220554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date December 16, 2022
Days to Decision 291 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.