Definition: To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
| Device Type ID | 3636 |
| Device Name | Neurosurgical Nerve Locator |
| Physical State | A User Interface/control Unit; Handpiece With Tip To Deliver The Electric Current; And A Separate Monitoring Electrode If Detection Is Not Built In The Same Tip. |
| Technical Method | Sends Out Electrical Current, Monitors For This Current, And Informs User Of A Change From Baseline. |
| Target Area | Spinal Nerve Roots Or Peripheral Nerves |
| Regulation Description | Surgical Nerve Stimulator/locator. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.1820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3636 |
| Device | Neurosurgical Nerve Locator |
| Product Code | PDQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Nerve Stimulator/locator. |
| CFR Regulation Number | 874.1820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET SPINE (AKA EBI, LLC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDOS INTERNATIONAL, SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RHYTHMLINK INTERNATIONAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SI-BONE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEGUARD, S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEDAN SURGICAL INNOVATIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6 |
Failure To Read Input Signal | 4 |
Monitor | 2 |
Break | 2 |
Needle | 1 |
False Negative Result | 1 |
Failure To Sense | 1 |
| Total Device Problems | 17 |