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- 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
- K252962DYNAMIS™ Navigation System2Cleared 510(K)
- K253661TMINI Miniature Robotic System2Cleared 510(K)
- K252950Paradigm System2Cleared 510(K)
- K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)2Cleared 510(K)
- K251943Spineology Navigation Instruments2Cleared 510(K)
- K251314Rosa® Knee System2Cleared 510(K)
- K250599ExcelsiusGPS™ Instruments2Cleared 510(K)
- K252088Firebird SI Navigation System2Cleared 510(K)
- K252742Navigated Instruments2Cleared 510(K)
- K250520OsteoCentric Navigated Instruments System2Cleared 510(K)
Show All 424 Submissions
- ONNIntraoperative Orthopedic Joint Assessment Aid2Product Code
- OSEPatient Specific Manual Navigation System2Product Code
- SBFOrthopedic Augmented Reality2Product Code
- 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
ExcelsiusGPS™ Instruments
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K250599
- 510(k) Type
- Traditional
- Applicant
- Globus Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/5/2025
- Days to Decision
- 250 days
- Submission Type
- Summary