Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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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)
- K181559Neurosign V4 Intraoperative Nerve Monitor2Cleared 510(K)
- K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe2Cleared 510(K)
- K173526SENTIO MMG Gen 22Cleared 510(K)
- K173134SENTIO MMG Pedicle Access Needles2Cleared 510(K)
- K171807ES2 Neuromonitoring Accessory Instruments2Cleared 510(K)
- K162313NuVasive Next Generation NVM5 System2Cleared 510(K)
- K161893Neuromonitoring Kit2Cleared 510(K)
- K152747DSG Threaded Drill System2Cleared 510(K)
- K152942NuVasiveNVM5 System2Cleared 510(K)
- K143641NuVasive NVM5 System2Cleared 510(K)
- K142438Nerve Monitoring Cable System2Cleared 510(K)
- K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS2Cleared 510(K)
- K141968NUVASIVE NVM5 SYSTEM2Cleared 510(K)
- K140088PHANTOM XL INSULATED DILATORS2Cleared 510(K)
- K131304SENTIO MMG2Cleared 510(K)
- K132694NUVASIVE NVM5 SYSTEM2Cleared 510(K)
- K133530NUVASIVE EMG ENDOTRACHEAL TUBE2Cleared 510(K)
- K132138RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE2Cleared 510(K)
- K132373BIOMET ACCESS SYSTEM2Cleared 510(K)
- K123390PEDIGUARD NERVE DETECTOR SYSTEM2Cleared 510(K)
- K130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE2Cleared 510(K)
- K120590DILATOR TUBE SET2Cleared 510(K)
- K123307NUVASIVE NVM5 SYSTEM2Cleared 510(K)
- K123589CADWELL DISPOSABLE PROBE HANDLE2Cleared 510(K)
- 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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
Neuromonitoring Kit
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161893
- 510(k) Type
- Traditional
- Applicant
- SI-BONE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/18/2016
- Days to Decision
- 99 days
- Submission Type
- Summary