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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
K
25
2962
DYNAMIS™ Navigation System
2
Cleared 510(K)
K
25
3661
TMINI Miniature Robotic System
2
Cleared 510(K)
K
25
2950
Paradigm System
2
Cleared 510(K)
K
25
2841
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
2
Cleared 510(K)
K
25
1943
Spineology Navigation Instruments
2
Cleared 510(K)
K
25
1314
Rosa® Knee System
2
Cleared 510(K)
K
25
0599
ExcelsiusGPS™ Instruments
2
Cleared 510(K)
K
25
2088
Firebird SI Navigation System
2
Cleared 510(K)
K
25
2742
Navigated Instruments
2
Cleared 510(K)
K
25
0520
OsteoCentric Navigated Instruments System
2
Cleared 510(K)
Show All 424 Submissions
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
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
/
OLO
/
K252088
View Source
Firebird SI Navigation System
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
K
25
2962
DYNAMIS™ Navigation System
K
25
3661
TMINI Miniature Robotic System
K
25
2950
Paradigm System
K
25
2841
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K
25
1943
Spineology Navigation Instruments
K
25
1314
Rosa® Knee System
K
25
0599
ExcelsiusGPS™ Instruments
K
25
2088
Firebird SI Navigation System
K
25
2742
Navigated Instruments
K
25
0520
OsteoCentric Navigated Instruments System
Show All 424 Submissions
ONN
Intraoperative Orthopedic Joint Assessment Aid
OSE
Patient Specific Manual Navigation System
SBF
Orthopedic Augmented Reality
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-e—neurological-surgical-devices
/
OLO
/
K252088
View Source
Firebird SI Navigation System
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...