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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
- K250086OTS Hip2Cleared 510(K)
- K243419Altus Spine Navigation System2Cleared 510(K)
- K250608Mako Total Knee Application (3.0); Hybrid Tip Pointer2Cleared 510(K)
- K243326Dynamis Robotic Surgical System2Cleared 510(K)
- K242806Medyssey Navigation System2Cleared 510(K)
- K243514Salvo® Robotic Navigation Instruments2Cleared 510(K)
- K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments2Cleared 510(K)
- K250182Innovasis Navigation Instruments2Cleared 510(K)
- K243958Consolidated Operating Room Equipment (CORE) 2 Console2Cleared 510(K)
- K242121mBôs (Monogram mBôs TKA System)2Cleared 510(K)
Show All 400 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
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- UnknownReview Panel
OTS Hip
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K250086
- 510(k) Type
- Traditional
- Applicant
- Ortoma AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/16/2025
- Days to Decision
- 123 days
- Submission Type
- Summary