510(k) K242271
K242271 is an FDA 510(k) premarket notification submitted by Taiwan Main Orthopaedic Biotechnology Co., Ltd. for the device "Caduceus S". The FDA issued a decision of Substantially Equivalent on October 30, 2024. The device falls under product code SBF (Orthopedic Augmented Reality), a Class II device regulated under 21 CFR 882.4560. Taiwan Main Orthopaedic Biotechnology Co., Ltd. has at least 1 other 510(k) clearance on record.
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 users field of view.