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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
- ONNIntraoperative Orthopedic Joint Assessment Aid2Product Code
- K252524Quadsense (Quadsense and Quadsense Pro)2Cleared 510(K)
- K241298QUADSENSE2Cleared 510(K)
- K242616Lantern® Hip2Cleared 510(K)
- K220830TrueBalance™ Surgical System2Cleared 510(K)
- K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder2Cleared 510(K)
- K200665VERASENSE for Stryker Triathlon2Cleared 510(K)
- K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left2Cleared 510(K)
- K180459VERASENSE for Zimmer Biomet Persona2Cleared 510(K)
- K162237XO1 Knee Balancing System2Cleared 510(K)
- K150372VERASENSE Knee System2Cleared 510(K)
Show All 16 Submissions
- 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
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K200587
- 510(k) Type
- Traditional
- Applicant
- Orthosensor, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/25/2020
- Days to Decision
- 172 days
- Submission Type
- Summary