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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
OSF
Patient Specific Manual Orthopedic Stereotaxic System
2
Product Code
OJP
Orthopedic Computer Controlled Surgical System
2
Product Code
OLO
Orthopedic Stereotaxic Instrument
2
Product Code
ONN
Intraoperative Orthopedic Joint Assessment Aid
2
Product Code
OSE
Patient Specific Manual Navigation System
2
Product Code
SBF
Orthopedic Augmented Reality
2
Product Code
K
25
2847
NextAR Hip Platform
2
Cleared 510(K)
K
25
1639
xvision Spine system
2
Cleared 510(K)
K
25
2054
SpineAR SNAP (SyncAR Spine)
2
Cleared 510(K)
K
25
2530
OptiVu™ Shoulder
2
Cleared 510(K)
K
25
1737
NextAR(TM) Shoulder Platform
2
Cleared 510(K)
K
25
2170
OptiVu™ Shoulder
2
Cleared 510(K)
K
25
0477
NextAR(TM) Spine
2
Cleared 510(K)
K
25
0108
OptiVu™ Shoulder
2
Cleared 510(K)
K
24
1525
ExcelsiusXR™
2
Cleared 510(K)
K
24
2569
Mixed Reality Spine Navigation
2
Cleared 510(K)
Show All 18 Submissions
Subpart E—Surgical Devices
CFR Sub-Part
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
OR
/
subpart-e—neurological-surgical-devices
/
SBF
/
K242569
View Source
Mixed Reality Spine Navigation
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
OSF
Patient Specific Manual Orthopedic Stereotaxic System
OJP
Orthopedic Computer Controlled Surgical System
OLO
Orthopedic Stereotaxic Instrument
ONN
Intraoperative Orthopedic Joint Assessment Aid
OSE
Patient Specific Manual Navigation System
SBF
Orthopedic Augmented Reality
K
25
2847
NextAR Hip Platform
K
25
1639
xvision Spine system
K
25
2054
SpineAR SNAP (SyncAR Spine)
K
25
2530
OptiVu™ Shoulder
K
25
1737
NextAR(TM) Shoulder Platform
K
25
2170
OptiVu™ Shoulder
K
25
0477
NextAR(TM) Spine
K
25
0108
OptiVu™ Shoulder
K
24
1525
ExcelsiusXR™
K
24
2569
Mixed Reality Spine Navigation
Show All 18 Submissions
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-e—neurological-surgical-devices
/
SBF
/
K242569
View Source
Mixed Reality Spine Navigation
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...