Neurology · 510(k) · 2018
NuVasive Pulse System
NuVasive, Incorporated. Cleared by FDA on 29 June 2018 under submission K180038, product code OLO (orthopedic stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K180038
- Device. NuVasive Pulse SystemDEVICE
- Company. NuVasive, IncorporatedCOMPANY
- Decision. 29 June 2018, 510(k), substantially equivalent (traditional review); received 5 January 2018DECISION
- Panel. NeurologyPANEL
- Product code. OLO, Orthopedic Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a […]
The product code's definition, from FDA's classification record. Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 20,865 reports filed against devices carrying product code OLO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00510
Screws loose Case Type / Application: THA 5.0.
30 September 2026 · Malfunction · Stealth AXiS · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01387
Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure. It was reported that the trajectories could not be reached. All were marked as red. The site attempted to reposition to R-L5 and the trajectory guide ran into the patient reference frame clamped on L4. Surgeon grabbed the arm to stop it using the force sensor. Performed anatomy checks with probe to confirm accuracy. Accuracy was confirmed and the procedure […]
30 September 2026 · Malfunction · NAVLOCK · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01388
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that the probes tip broke. Delay and patient impact were not reported.
30 September 2026 · Injury · 5.5mm Tap, Navigation · Orthopediatrics · report 3006460162-2026-00057
29 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00503
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OLO, in Neurology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.