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- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- K230463NSite Scoliosis Assessment AppUCleared 510(K)
- K232023Momentum SpineUCleared 510(K)
- K183485CryoVizion SystemUCleared 510(K)
- K923792QUANTEC SPINAL MEASUEMENT SYSTEMUCleared 510(K)
- K860225METRICOMUCleared 510(K)
- K851133TERRAN BIOMECHANICAL ANALYSIS SYSTEMUCleared 510(K)
- K844736ISISUCleared 510(K)
- K800591CONTOUROGRAPH M-500UCleared 510(K)
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
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Momentum Spine
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K232023
- 510(k) Type
- Traditional
- Applicant
- Momentum Health, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/4/2023
- Days to Decision
- 89 days
- Submission Type
- Summary