Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

PULSE

Model LNPULSELRTABLET · Nuvasive, Inc. · DI 00195377081674

ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820

GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870

HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560

IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375

JAA — System, X-Ray, Fluoroscopic, Image-Intensified · Class II · 21 CFR 892.1650

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

OWB — Interventional Fluoroscopic X-Ray System · Class II · 21 CFR 892.1650

PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

122537502019-01: 0 reports for this device; peer average 7.92/device2019-02: 0 reports for this device; peer average 8.38/device2019-03: 0 reports for this device; peer average 8.59/device2019-04: 0 reports for this device; peer average 9.7/device2019-05: 0 reports for this device; peer average 10.9/device2019-06: 0 reports for this device; peer average 10.85/device2019-07: 0 reports for this device; peer average 7.98/device2019-08: 0 reports for this device; peer average 7.26/device2019-09: 0 reports for this device; peer average 6.66/device2019-10: 0 reports for this device; peer average 6.54/device2019-11: 0 reports for this device; peer average 8.23/device2019-12: 0 reports for this device; peer average 8.63/device2020-01: 0 reports for this device; peer average 6.54/device2020-02: 0 reports for this device; peer average 7.76/device2020-03: 0 reports for this device; peer average 8.57/device2020-04: 0 reports for this device; peer average 7.72/device2020-05: 0 reports for this device; peer average 8.4/device2020-06: 0 reports for this device; peer average 7.05/device2020-07: 0 reports for this device; peer average 7.85/device2020-08: 0 reports for this device; peer average 6.63/device2020-09: 0 reports for this device; peer average 6.88/device2020-10: 0 reports for this device; peer average 7.84/device2020-11: 0 reports for this device; peer average 8.07/device2020-12: 0 reports for this device; peer average 6.92/device2021-01: 0 reports for this device; peer average 7.11/device2021-02: 0 reports for this device; peer average 7.52/device2021-03: 0 reports for this device; peer average 7.36/device2021-04: 0 reports for this device; peer average 6.83/device2021-05: 0 reports for this device; peer average 7.49/device2021-06: 0 reports for this device; peer average 8.25/device2021-07: 0 reports for this device; peer average 6.73/device2021-08: 0 reports for this device; peer average 7.59/device2021-09: 0 reports for this device; peer average 10.26/device2021-10: 0 reports for this device; peer average 6.89/device2021-11: 0 reports for this device; peer average 8.38/device2021-12: 0 reports for this device; peer average 6.35/device2022-01: 0 reports for this device; peer average 5.92/device2022-02: 0 reports for this device; peer average 5.74/device2022-03: 0 reports for this device; peer average 7.65/device2022-04: 0 reports for this device; peer average 5.78/device2022-05: 0 reports for this device; peer average 7.32/device2022-06: 0 reports for this device; peer average 7.31/device2022-07: 0 reports for this device; peer average 6.1/device2022-08: 0 reports for this device; peer average 6.62/device2022-09: 0 reports for this device; peer average 6.32/device2022-10: 0 reports for this device; peer average 12.51/device2022-11: 0 reports for this device; peer average 19.48/device2022-12: 0 reports for this device; peer average 16.88/device2023-01: 0 reports for this device; peer average 19.69/device2023-02: 0 reports for this device; peer average 13.81/device2023-03: 0 reports for this device; peer average 23.02/device2023-04: 0 reports for this device; peer average 15.87/device2023-05: 0 reports for this device; peer average 21.73/device2023-06: 0 reports for this device; peer average 18.62/device2023-07: 0 reports for this device; peer average 14.97/device2023-08: 0 reports for this device; peer average 15.96/device2023-09: 0 reports for this device; peer average 19.1/device2023-10: 0 reports for this device; peer average 16.83/device2023-11: 0 reports for this device; peer average 20.31/device2023-12: 0 reports for this device; peer average 19.44/device2024-01: 0 reports for this device; peer average 19.53/device2024-02: 0 reports for this device; peer average 23.53/device2024-03: 0 reports for this device; peer average 18.97/device2024-04: 0 reports for this device; peer average 18.12/device2024-05: 0 reports for this device; peer average 18.75/device2024-06: 0 reports for this device; peer average 16.65/device2024-07: 0 reports for this device; peer average 19.74/device2024-08: 0 reports for this device; peer average 23.63/device2024-09: 0 reports for this device; peer average 23.76/device2024-10: 0 reports for this device; peer average 23.93/device2024-11: 0 reports for this device; peer average 18.63/device2024-12: 0 reports for this device; peer average 17.53/device2025-01: 0 reports for this device; peer average 18.14/device2025-02: 0 reports for this device; peer average 22.24/device2025-03: 0 reports for this device; peer average 19.1/device2025-04: 0 reports for this device; peer average 24.36/device2025-05: 0 reports for this device; peer average 22.96/device2025-06: 0 reports for this device; peer average 26.21/device2025-07: 0 reports for this device; peer average 27.35/device2025-08: 0 reports for this device; peer average 32.28/device2025-09: 0 reports for this device; peer average 49.75/device2025-10: 0 reports for this device; peer average 48.18/device2025-11: 0 reports for this device; peer average 34.41/device2025-12: 0 reports for this device; peer average 16.85/device2026-01: 0 reports for this device; peer average 17.19/device2026-02: 0 reports for this device; peer average 13.81/device2026-03: 0 reports for this device; peer average 15.74/device2026-04: 0 reports for this device; peer average 14.18/device2026-05: 0 reports for this device; peer average 15.74/device2026-06: 0 reports for this device; peer average 13.57/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0107.92
2019-0208.38
2019-0308.59
2019-0409.7
2019-05010.9
2019-06010.85
2019-0707.98
2019-0807.26
2019-0906.66
2019-1006.54
2019-1108.23
2019-1208.63
2020-0106.54
2020-0207.76
2020-0308.57
2020-0407.72
2020-0508.4
2020-0607.05
2020-0707.85
2020-0806.63
2020-0906.88
2020-1007.84
2020-1108.07
2020-1206.92
2021-0107.11
2021-0207.52
2021-0307.36
2021-0406.83
2021-0507.49
2021-0608.25
2021-0706.73
2021-0807.59
2021-09010.26
2021-1006.89
2021-1108.38
2021-1206.35
2022-0105.92
2022-0205.74
2022-0307.65
2022-0405.78
2022-0507.32
2022-0607.31
2022-0706.1
2022-0806.62
2022-0906.32
2022-10012.51
2022-11019.48
2022-12016.88
2023-01019.69
2023-02013.81
2023-03023.02
2023-04015.87
2023-05021.73
2023-06018.62
2023-07014.97
2023-08015.96
2023-09019.1
2023-10016.83
2023-11020.31
2023-12019.44
2024-01019.53
2024-02023.53
2024-03018.97
2024-04018.12
2024-05018.75
2024-06016.65
2024-07019.74
2024-08023.63
2024-09023.76
2024-10023.93
2024-11018.63
2024-12017.53
2025-01018.14
2025-02022.24
2025-03019.1
2025-04024.36
2025-05022.96
2025-06026.21
2025-07027.35
2025-08032.28
2025-09049.75
2025-10048.18
2025-11034.41
2025-12016.85
2026-01017.19
2026-02013.81
2026-03015.74
2026-04014.18
2026-05015.74
2026-06013.57
This device (reports/month)Average device in ETN, GWF, HAW, IKN, JAA, LLZ, OLO, OWB, PDQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K210574 — cites (transitively): K170011 (d1), K180038 (d1), K200719 (d1), K050438 (d2), K153660 (d2), K162313 (d2), K172623 (d2), K173314 (d2), K112709 (d2), K192336 (d2), K150216 (d3), K992927 (d3), K083124 (d3), K132694 (d3), K152942 (d3), K140454 (d3), K153203 (d3), K153603 (d3), K142243 (d3), K170800 (d3), K124004 (d3), K150231 (d3), K191039 (d3), K092744 (d4), K123307 (d4), K123226 (d4), K132970 (d4), K131425 (d4), K143641 (d4), K143375 (d4), K143628 (d4), K123623 (d4), K133221 (d4), K143149 (d4), K152968 (d4), K163581 (d4), K173125 (d4), K013841 (d5), K122742 (d5), K033090 (d5), K042673 (d5), K071890 (d5), K073291 (d5), K083026 (d5), K103731 (d5), K112405 (d5), K100685 (d5), K091974 (d5), K102555 (d5), K113529 (d5), K132639 (d5), K141605 (d5), K142847 (d5), K141968 (d5), K013440 (d5), K142591 (d5), K142798 (d5), K142559 (d5), K052931 (d5), K071033 (d5), K083186 (d5), K100976 (d5), K003836 (d6), K010930 (d6), K082112 (d6), K091883 (d6), K033621 (d6), K052747 (d6), K122862 (d6), K072970 (d6), K083626 (d6), K094025 (d6), K102293 (d6), K113447 (d6), K121333 (d6), K122037 (d6), K123027 (d6), K031655 (d6), K042025 (d6), K052187 (d6), K141494 (d6), K123138 (d6), K113174 (d6), K052261 (d7), P950019 (d7), P960025 (d7), K093242 (d7), K030327 (d7), K073285 (d7), K091813 (d7), K094042 (d7), K100214 (d7), K082732 (d7), K140276 (d7), K091088 (d8), K092336 (d8), P000028 (d8), P980048 (d8), K091445 (d8), K111457 (d8), K132328 (d8), K132471 (d8) — cited as predicate by K223841, K230989, K243814

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Nuvasive, Inc.

  • Warning Letter 2013-03-12 NuVasive Inc
  • Warning Letter 2013-03-12 NuVasive Inc
  • VAI 2024-05-06 NuVasive Specialized Orthopedics, Inc. · 12 citations
  • NAI 2024-01-18 Nuvasive PR, Inc. · 0 citations
  • NAI 2019-12-09 Nuvasive PR, Inc. · 0 citations
  • NAI 2019-07-29 NuVasive, Inc · 0 citations
  • NAI 2017-05-31 Nuvasive PR, Inc. · 0 citations
  • VAI 2017-05-26 NuVasive Inc · 2 citations
  • VAI 2017-05-26 NuVasive Inc · 2 citations
  • VAI 2017-05-04 NuVasive, Inc · 3 citations
  • VAI 2016-10-26 Nuvasive Inc · 2 citations
  • NAI 2014-11-19 NuVasive Inc · 0 citations
  • NAI 2014-11-19 NuVasive Inc · 0 citations
  • NAI 2014-08-27 Nuvasive Inc · 4 citations
  • NAI 2014-04-01 Nuvasive PR, Inc. · 0 citations
  • NAI 2014-02-20 NuVasive Specialized Orthopedics, Inc. · 0 citations
  • NAI 2014-02-05 NuVasive Inc · 0 citations
  • NAI 2014-02-05 NuVasive Inc · 0 citations
  • OAI 2012-11-02 NuVasive Inc · 0 citations
  • OAI 2012-11-02 NuVasive Inc · 0 citations
  • NAI 2012-02-10 NuVasive Inc · 0 citations
  • NAI 2012-02-10 NuVasive Inc · 0 citations