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Orthopedic Augmented Reality

SBF · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560

Classification

FDA Product Code
SBF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.4560
Review panel
OR
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
42
Registered establishments
35

Source

Authoritative
FDA Device Classification database
Machine
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