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FDA PRODUCT CODE · CLASS II

SBF — Orthopedic Augmented Reality

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.4560
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES

Recent clearances

K253805Pixee Medical S.A.S. · 510k2026-04-24
K252847Medacta International S.A. · 510k2026-01-09
K251639Augmedics, Ltd. · 510k2025-10-03
K252054Surgical Theater, Inc. · 510k2025-09-29
K252530Mr Surgical Solutions, LLC · 510k2025-09-10
K251737Medacta International S.A. · 510k2025-09-04
K252170Mr Surgical Solutions, LLC · 510k2025-08-08
K250477Medacta International S.A. · 510k2025-07-31

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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