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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PDQNeurosurgical Nerve Locator2Product Code
- K243636Neuralytix iD3 System (NTX-9001)2Cleared 510(K)
- K223438TELIGEN System Peripheral Motor Nerve Stimulation Indications2Cleared 510(K)
- K221821ATEC IOM Accessory Instruments2Cleared 510(K)
- K220160PediGuard Threaded2Cleared 510(K)
- K203684Neurosign V4 Intraoperative Nerve Monitor2Cleared 510(K)
- K201454DSG Connect Technology2Cleared 510(K)
- K191723ATEC IOM Accessory Instruments2Cleared 510(K)
- K190163ALARA Neuro Access Kit2Cleared 510(K)
- K182617ATEC IOM Accessory Instruments2Cleared 510(K)
- K182662NAV PAK Needle, NIM NAV PAK Needle2Cleared 510(K)
Show All 34 Submissions
- HRWDynamometer, Nonpowered1Product Code
- KQWGoniometer, Nonpowered1Product Code
- KQXGoniometer, Ac-Powered1Product Code
- LBBDynamometer, Ac-Powered2Product Code
- NKIGoniometer With Electrodes2Product Code
- QWPOptical Neurosurgical Nerve Locator2Product Code
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Neuralytix iD3 System (NTX-9001)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K243636
- 510(k) Type
- Traditional
- Applicant
- Neuralytix, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/26/2025
- Days to Decision
- 213 days
- Submission Type
- Summary