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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
K
23
3315
HipXpert and HipInsight System
2
Cleared 510(K)
K
20
0384
HipXpert 3D Display and Anchoring Application
2
Cleared 510(K)
K
09
3491
HIP SEXTANT INSTRUMENT SYSTEM
2
Cleared 510(K)
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
Subpart E—Surgical Devices
CFR Sub-Part
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
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Medical Genetics
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Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
OR
/
subpart-e—neurological-surgical-devices
/
OSF
/
K093491
View Source
HIP SEXTANT INSTRUMENT SYSTEM
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K093491
510(k) Type
Traditional
Applicant
Surgical Planning Associates
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/2010
Days to Decision
394 days
Submission Type
Summary
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
K
23
3315
HipXpert and HipInsight System
K
20
0384
HipXpert 3D Display and Anchoring Application
K
09
3491
HIP SEXTANT INSTRUMENT 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
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-e—neurological-surgical-devices
/
OSF
/
K093491
View Source
HIP SEXTANT INSTRUMENT SYSTEM
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K093491
510(k) Type
Traditional
Applicant
Surgical Planning Associates
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/2010
Days to Decision
394 days
Submission Type
Summary