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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
- K250599ExcelsiusGPS™ Instruments2Cleared 510(K)
- K252088Firebird SI Navigation System2Cleared 510(K)
- K252742Navigated Instruments2Cleared 510(K)
- K250520OsteoCentric Navigated Instruments System2Cleared 510(K)
- K251282StealthStation S8 Spine Software2Cleared 510(K)
- K252544TMINI Miniature Robotic System2Cleared 510(K)
- K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer2Cleared 510(K)
- K251780iGPS Navigation Instruments2Cleared 510(K)
- K252562Spine & Trauma Navigation Instruments2Cleared 510(K)
- K251316Mazor X System / Mazor X Stealth Edition2Cleared 510(K)
Show All 418 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
StealthStation S8 Spine Software
- Page Type
- Cleared 510(K)
- 510(k) Number
- K251282
- 510(k) Type
- Traditional
- Applicant
- Medtronic Navigation, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/17/2025
- Days to Decision
- 176 days
- Submission Type
- Summary