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510(k) K242271

Caduceus S by Taiwan Main Orthopaedic Biotechnology Co., Ltd. — Product Code SBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2024
Date Received
August 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Augmented Reality
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

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.

Other clearances by Taiwan Main Orthopaedic Biotechnology Co., Ltd.

  • K220554 — Caduceus S (December 16, 2022)

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