Anesthesiology
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- 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
- 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)
- K250167Evolution Spine Navigation Instruments2Cleared 510(K)
- K251060CORUS™ Navigation System-GX2Cleared 510(K)
- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)2Cleared 510(K)
- K250877TMINI Miniature Robotic System2Cleared 510(K)
- K242933SPINEART Navigation Instrument System2Cleared 510(K)
- K242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts2Cleared 510(K)
Show All 412 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
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
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