Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- OSFPatient Specific Manual Orthopedic Stereotaxic System2Product Code
- OJPOrthopedic Computer Controlled Surgical System2Product Code
- OLOOrthopedic Stereotaxic Instrument2Product Code
- ONNIntraoperative Orthopedic Joint Assessment Aid2Product Code
- OSEPatient Specific Manual Navigation System2Product Code
- SBFOrthopedic Augmented Reality2Product Code
- K252847NextAR Hip Platform2Cleared 510(K)
- K251639xvision Spine system2Cleared 510(K)
- K252054SpineAR SNAP (SyncAR Spine)2Cleared 510(K)
- K252530OptiVu™ Shoulder2Cleared 510(K)
- K251737NextAR(TM) Shoulder Platform2Cleared 510(K)
- K252170OptiVu™ Shoulder2Cleared 510(K)
- K250477NextAR(TM) Spine2Cleared 510(K)
- K250108OptiVu™ Shoulder2Cleared 510(K)
- K241525ExcelsiusXR™2Cleared 510(K)
- K242569Mixed Reality Spine Navigation2Cleared 510(K)
- K243980ARVIS Surgical Navigation System2Cleared 510(K)
- K243975Knee+2Cleared 510(K)
- K250255xvision Spine system2Cleared 510(K)
- K243950ARVIS® Shoulder2Cleared 510(K)
- K243623SpineAR SNAP (SyncAR Spine)2Cleared 510(K)
- K242271Caduceus S2Cleared 510(K)
- K241481xvision Spine System2Cleared 510(K)
- K241870OnPoint Augmented Reality Spine System2Cleared 510(K)
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ARVIS Surgical Navigation System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K243980
- 510(k) Type
- Special
- Applicant
- Kico Knee Innovation Company Pty Limited
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/21/2025
- Days to Decision
- 88 days
- Submission Type
- Summary