BEUDAMED
    Product Code: SBF FDA class 2 21 CFR 882.4560

    Orthopedic Augmented Reality

    Neurology

    An orthopedic augmented reality device provides visual guidance during orthopedic procedures using stereotaxic navigation, displaying augmented reality stereoscopic images to intraoperatively augment the surgeon's field of view for improved procedural accuracy. It is classified as FDA Class II (510(k) required) under regulation 882.4560 in the Neurology specialty (reviewed by the Orthopedic panel), with product code SBF. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    42
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    16
    Years Active
    6

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    Basic Information

    Product Code
    SBF
    Device Class
    FDA class 2
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 42 510(k) clearances via K numbers.

    K Number Device Name
    K253805 Knee+
    K252847 NextAR Hip Platform
    K251639 xvision Spine system
    K252054 SpineAR SNAP (SyncAR Spine)
    K252530 OptiVu™ Shoulder
    K251737 NextAR(TM) Shoulder Platform
    K252170 OptiVu™ Shoulder
    K250477 NextAR(TM) Spine
    K250108 OptiVu™ Shoulder
    K241525 ExcelsiusXR™
    K242569 Mixed Reality Spine Navigation
    K243980 ARVIS Surgical Navigation System
    K243975 Knee+
    K250255 xvision Spine system
    K243950 ARVIS® Shoulder
    K243623 SpineAR SNAP (SyncAR Spine)
    K242271 Caduceus S
    K241481 xvision Spine System
    K241870 OnPoint Augmented Reality Spine System
    K233172 NextAR™ Spine Platform
    K233899 Knee+
    K232176 STELLAR Knee
    K232280 NextAR™ TSA Platform
    K231284 OnPoint Augmented Reality Spine System
    K231611 HOLO Portal™ Surgical Guidance System
    K223769 NextAR™ Spine Platform
    K230567 OptiVu™ ROSA® MxR
    K230789 Knee+
    K220554 Caduceus S
    K220905 xvision Spine System
    K213034 SpineAR SNAP
    K220104 Knee+
    K220733 OptiVu ROSA MxR
    K213751 NextAR™ TKA Platform My Knee PPS
    K211254 ARAI Surgical Navigation System
    K210859 NextAR™ Spine Platform
    K211188 xvision Spine system (XVS)
    K210153 NextAR RSA Platform
    K202750 Knee+
    K202152 NextAR TKA Platform
    K193559 NextAR TKA Platform
    K190929 xvision Spine system (XVS)

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.