510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SBFClass II

Orthopedic Augmented Reality

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

SBF is the FDA product code for Orthopedic Augmented Reality, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "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". As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
SBF
Device name
Orthopedic Augmented Reality
FDA 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.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
43
Ingested recalls
2

Clearances, product code SBF

By decision year
43 clearances under product code SBF with a decision year between 2019 and 2026, 2025 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code SBF by decision year
YearClearances
20191
20202
20214
20227
20237
20246
202513
20263

Applicants with the most clearances

Product code SBF
Applicants holding the most 510(k) clearances under product code SBF
ApplicantClearances
Medacta International SA10
Augmedics Ltd.7
Pixee Medical5
Mr Surgical Solutions, LLC3
Surgical Theater Inc3
Kico Knee Innovation Company2
Onpoint Surgical2
Orthosoft Inc (D/B/A Zimmer Cas)2
Surgalign Spine Technologies2
Taiwan Main Orthopaedic Biotechnology Co., Ltd2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order