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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
1971
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
2
Cleared 510(K)
K
25
1780
iGPS Navigation Instruments
2
Cleared 510(K)
K
25
2562
Spine & Trauma Navigation Instruments
2
Cleared 510(K)
K
25
1316
Mazor X System / Mazor X Stealth Edition
2
Cleared 510(K)
K
25
0167
Evolution Spine Navigation Instruments
2
Cleared 510(K)
K
25
1060
CORUS™ Navigation System-GX
2
Cleared 510(K)
K
25
1073
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
2
Cleared 510(K)
K
25
0877
TMINI Miniature Robotic System
2
Cleared 510(K)
K
24
2933
SPINEART Navigation Instrument System
2
Cleared 510(K)
K
24
2464
Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
2
Cleared 510(K)
Show All 412 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 12 October 2025 at 8:21 pm
OR
/
subpart-e—neurological-surgical-devices
/
OLO
/
K250877
View Source
TMINI Miniature Robotic System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
1971
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
K
25
1780
iGPS Navigation Instruments
K
25
2562
Spine & Trauma Navigation Instruments
K
25
1316
Mazor X System / Mazor X Stealth Edition
K
25
0167
Evolution Spine Navigation Instruments
K
25
1060
CORUS™ Navigation System-GX
K
25
1073
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
K
25
0877
TMINI Miniature Robotic System
K
24
2933
SPINEART Navigation Instrument System
K
24
2464
Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
Show All 412 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
/
K250877
View Source
TMINI Miniature Robotic System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...