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MIDAS REX STEALTH-MIDAS MR8

Model PM800N · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000431020

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

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

UDILibrary device dossier · generated 2026-09-14 · 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.

5914192019-01: 0 reports for this device; peer average 9.11/device2019-02: 0 reports for this device; peer average 9.71/device2019-03: 0 reports for this device; peer average 9.79/device2019-04: 0 reports for this device; peer average 11.87/device2019-05: 0 reports for this device; peer average 13.04/device2019-06: 0 reports for this device; peer average 13.02/device2019-07: 0 reports for this device; peer average 9.88/device2019-08: 0 reports for this device; peer average 7.49/device2019-09: 0 reports for this device; peer average 7.85/device2019-10: 0 reports for this device; peer average 7.27/device2019-11: 0 reports for this device; peer average 9.91/device2019-12: 0 reports for this device; peer average 10.08/device2020-01: 0 reports for this device; peer average 8.04/device2020-02: 0 reports for this device; peer average 9.15/device2020-03: 0 reports for this device; peer average 9.62/device2020-04: 0 reports for this device; peer average 9.53/device2020-05: 0 reports for this device; peer average 11.43/device2020-06: 0 reports for this device; peer average 8.71/device2020-07: 0 reports for this device; peer average 9.7/device2020-08: 0 reports for this device; peer average 8.58/device2020-09: 0 reports for this device; peer average 8.91/device2020-10: 0 reports for this device; peer average 9.9/device2020-11: 0 reports for this device; peer average 10.94/device2020-12: 0 reports for this device; peer average 9.27/device2021-01: 0 reports for this device; peer average 9.05/device2021-02: 0 reports for this device; peer average 9.77/device2021-03: 0 reports for this device; peer average 9.35/device2021-04: 0 reports for this device; peer average 8.9/device2021-05: 0 reports for this device; peer average 9.8/device2021-06: 0 reports for this device; peer average 11.37/device2021-07: 0 reports for this device; peer average 8.74/device2021-08: 0 reports for this device; peer average 10.53/device2021-09: 0 reports for this device; peer average 13/device2021-10: 0 reports for this device; peer average 8.34/device2021-11: 0 reports for this device; peer average 11.01/device2021-12: 0 reports for this device; peer average 7.44/device2022-01: 0 reports for this device; peer average 6.82/device2022-02: 0 reports for this device; peer average 7.95/device2022-03: 0 reports for this device; peer average 9.35/device2022-04: 0 reports for this device; peer average 6.39/device2022-05: 0 reports for this device; peer average 8.87/device2022-06: 0 reports for this device; peer average 9.36/device2022-07: 0 reports for this device; peer average 8.79/device2022-08: 0 reports for this device; peer average 8.72/device2022-09: 0 reports for this device; peer average 8.74/device2022-10: 0 reports for this device; peer average 11.56/device2022-11: 0 reports for this device; peer average 10.32/device2022-12: 0 reports for this device; peer average 10.44/device2023-01: 0 reports for this device; peer average 9.14/device2023-02: 0 reports for this device; peer average 8.45/device2023-03: 0 reports for this device; peer average 10.04/device2023-04: 0 reports for this device; peer average 10.25/device2023-05: 0 reports for this device; peer average 10.82/device2023-06: 0 reports for this device; peer average 12.34/device2023-07: 0 reports for this device; peer average 14.14/device2023-08: 0 reports for this device; peer average 13.16/device2023-09: 0 reports for this device; peer average 11.4/device2023-10: 0 reports for this device; peer average 10.8/device2023-11: 0 reports for this device; peer average 14.61/device2023-12: 0 reports for this device; peer average 12.27/device2024-01: 0 reports for this device; peer average 16.51/device2024-02: 0 reports for this device; peer average 12.43/device2024-03: 0 reports for this device; peer average 14.98/device2024-04: 0 reports for this device; peer average 13.44/device2024-05: 0 reports for this device; peer average 12.95/device2024-06: 0 reports for this device; peer average 12.52/device2024-07: 0 reports for this device; peer average 13.91/device2024-08: 0 reports for this device; peer average 18.98/device2024-09: 0 reports for this device; peer average 14.7/device2024-10: 0 reports for this device; peer average 18.36/device2024-11: 0 reports for this device; peer average 10.72/device2024-12: 0 reports for this device; peer average 10.63/device2025-01: 0 reports for this device; peer average 12.32/device2025-02: 0 reports for this device; peer average 13.73/device2025-03: 0 reports for this device; peer average 12.56/device2025-04: 0 reports for this device; peer average 13.77/device2025-05: 0 reports for this device; peer average 13.22/device2025-06: 0 reports for this device; peer average 16.69/device2025-07: 0 reports for this device; peer average 12.44/device2025-08: 0 reports for this device; peer average 10.63/device2025-09: 0 reports for this device; peer average 11.02/device2025-10: 0 reports for this device; peer average 10.7/device2025-11: 0 reports for this device; peer average 9.45/device2025-12: 0 reports for this device; peer average 8.85/device2026-01: 0 reports for this device; peer average 10.24/device2026-02: 0 reports for this device; peer average 8.24/device2026-03: 0 reports for this device; peer average 8.88/device2026-04: 0 reports for this device; peer average 7.34/device2026-05: 0 reports for this device; peer average 7.59/device2026-06: 0 reports for this device; peer average 5.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.11
2019-0209.71
2019-0309.79
2019-04011.87
2019-05013.04
2019-06013.02
2019-0709.88
2019-0807.49
2019-0907.85
2019-1007.27
2019-1109.91
2019-12010.08
2020-0108.04
2020-0209.15
2020-0309.62
2020-0409.53
2020-05011.43
2020-0608.71
2020-0709.7
2020-0808.58
2020-0908.91
2020-1009.9
2020-11010.94
2020-1209.27
2021-0109.05
2021-0209.77
2021-0309.35
2021-0408.9
2021-0509.8
2021-06011.37
2021-0708.74
2021-08010.53
2021-09013
2021-1008.34
2021-11011.01
2021-1207.44
2022-0106.82
2022-0207.95
2022-0309.35
2022-0406.39
2022-0508.87
2022-0609.36
2022-0708.79
2022-0808.72
2022-0908.74
2022-10011.56
2022-11010.32
2022-12010.44
2023-0109.14
2023-0208.45
2023-03010.04
2023-04010.25
2023-05010.82
2023-06012.34
2023-07014.14
2023-08013.16
2023-09011.4
2023-10010.8
2023-11014.61
2023-12012.27
2024-01016.51
2024-02012.43
2024-03014.98
2024-04013.44
2024-05012.95
2024-06012.52
2024-07013.91
2024-08018.98
2024-09014.7
2024-10018.36
2024-11010.72
2024-12010.63
2025-01012.32
2025-02013.73
2025-03012.56
2025-04013.77
2025-05013.22
2025-06016.69
2025-07012.44
2025-08010.63
2025-09011.02
2025-10010.7
2025-1109.45
2025-1208.85
2026-01010.24
2026-0208.24
2026-0308.88
2026-0407.34
2026-0507.59
2026-0605.85
This device (reports/month)Average device in HAW, OLO (reports/device/month)

Regulatory clearances

  • K183644 SESE 2019-05-22 (k number procode)

Predicate lineage

K183644 — cites (transitively): K160713 (d1), K183515 (d1), K081475 (d2), K090112 (d2), K143628 (d2), K163182 (d2), K163565 (d2), K170312 (d2), K140454 (d3), K020069 (d3), K072315 (d3), K870157 (d3), K012457 (d3), K121264 (d3), K081277 (d4), K124004 (d4), K050438 (d5) — cited as predicate by K202552, K230064, K233638, K240568, K251316

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

Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS

  • NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations