510(k) K211254
K211254 is an FDA 510(k) premarket notification submitted by Surgalign Spine Technologies for the device "ARAI Surgical Navigation System". The FDA issued a decision of Substantially Equivalent on January 14, 2022. The device falls under product code SBF (Orthopedic Augmented Reality), a Class II device regulated under 21 CFR 882.4560. Surgalign Spine Technologies has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2022
- Date Received
- April 26, 2021
- 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.