510(k) K243623
K243623 is an FDA 510(k) premarket notification submitted by Surgical Theater, Inc. for the device "SpineAR SNAP (SyncAR Spine)". The FDA issued a decision of Substantially Equivalent on December 24, 2024. The device falls under product code SBF (Orthopedic Augmented Reality), a Class II device regulated under 21 CFR 882.4560. Surgical Theater, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2024
- Date Received
- November 25, 2024
- Clearance Type
- Special
- 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.