DeviceClearance

Product code SBF— Neurology

Knee+

Classification name
Orthopedic Augmented Reality
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
43
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SBF under 21 CFR 882.4560, via openFDA

Market context for product code SBF

FDA has cleared 43 devices under product code SBF between 2019 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SBF

Recent clearances under product code SBF

Data sourced from openFDA. This site is unofficial and independent of the FDA.