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Stealth AXiS

Model 9736667 · MEDTRONIC NAVIGATION, INC. · DI 00763000995300

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

UDILibrary device dossier · generated 2026-09-07 · 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.

25792019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 3.61/device2019-03: 0 reports for this device; peer average 3.19/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 2.93/device2019-09: 0 reports for this device; peer average 2.89/device2019-10: 0 reports for this device; peer average 3.84/device2019-11: 0 reports for this device; peer average 5.54/device2019-12: 0 reports for this device; peer average 3.54/device2020-01: 0 reports for this device; peer average 3.39/device2020-02: 0 reports for this device; peer average 4.56/device2020-03: 0 reports for this device; peer average 4.41/device2020-04: 0 reports for this device; peer average 7.69/device2020-05: 0 reports for this device; peer average 2.37/device2020-06: 0 reports for this device; peer average 3.54/device2020-07: 0 reports for this device; peer average 3.94/device2020-08: 0 reports for this device; peer average 2.61/device2020-09: 0 reports for this device; peer average 3.93/device2020-10: 0 reports for this device; peer average 5.63/device2020-11: 0 reports for this device; peer average 5.77/device2020-12: 0 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 4.68/device2021-02: 0 reports for this device; peer average 4.08/device2021-03: 0 reports for this device; peer average 3.82/device2021-04: 0 reports for this device; peer average 3.82/device2021-05: 0 reports for this device; peer average 4.15/device2021-06: 0 reports for this device; peer average 3.79/device2021-07: 0 reports for this device; peer average 3.25/device2021-08: 0 reports for this device; peer average 2.96/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 4.24/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 3.16/device2022-03: 0 reports for this device; peer average 3.32/device2022-04: 0 reports for this device; peer average 2.45/device2022-05: 0 reports for this device; peer average 3.91/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3.33/device2022-08: 0 reports for this device; peer average 2.9/device2022-09: 0 reports for this device; peer average 2.32/device2022-10: 0 reports for this device; peer average 3.76/device2022-11: 0 reports for this device; peer average 3.44/device2022-12: 0 reports for this device; peer average 4.22/device2023-01: 0 reports for this device; peer average 3.18/device2023-02: 0 reports for this device; peer average 3.44/device2023-03: 0 reports for this device; peer average 3.77/device2023-04: 0 reports for this device; peer average 3.26/device2023-05: 0 reports for this device; peer average 3.02/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 2.69/device2023-08: 0 reports for this device; peer average 2.51/device2023-09: 0 reports for this device; peer average 4.04/device2023-10: 0 reports for this device; peer average 3.21/device2023-11: 0 reports for this device; peer average 9.13/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3.71/device2024-02: 0 reports for this device; peer average 4.15/device2024-03: 0 reports for this device; peer average 4.4/device2024-04: 0 reports for this device; peer average 3.95/device2024-05: 0 reports for this device; peer average 4.89/device2024-06: 0 reports for this device; peer average 4.54/device2024-07: 0 reports for this device; peer average 3.92/device2024-08: 0 reports for this device; peer average 4.59/device2024-09: 0 reports for this device; peer average 4.53/device2024-10: 0 reports for this device; peer average 6.31/device2024-11: 0 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 0 reports for this device; peer average 8.37/device2025-02: 0 reports for this device; peer average 4.23/device2025-03: 0 reports for this device; peer average 3.59/device2025-04: 0 reports for this device; peer average 4.2/device2025-05: 0 reports for this device; peer average 4.57/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 4.32/device2025-08: 0 reports for this device; peer average 5.03/device2025-09: 0 reports for this device; peer average 3.85/device2025-10: 0 reports for this device; peer average 3.97/device2025-11: 0 reports for this device; peer average 4.12/device2025-12: 0 reports for this device; peer average 4.59/device2026-01: 0 reports for this device; peer average 4.53/device2026-02: 0 reports for this device; peer average 4.25/device2026-03: 0 reports for this device; peer average 4.08/device2026-04: 0 reports for this device; peer average 3.9/device2026-05: 0 reports for this device; peer average 4.99/device2026-06: 0 reports for this device; peer average 3.99/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0203.61
2019-0303.19
2019-0402.75
2019-0503.1
2019-0602.72
2019-0703.23
2019-0802.93
2019-0902.89
2019-1003.84
2019-1105.54
2019-1203.54
2020-0103.39
2020-0204.56
2020-0304.41
2020-0407.69
2020-0502.37
2020-0603.54
2020-0703.94
2020-0802.61
2020-0903.93
2020-1005.63
2020-1105.77
2020-1204.33
2021-0104.68
2021-0204.08
2021-0303.82
2021-0403.82
2021-0504.15
2021-0603.79
2021-0703.25
2021-0802.96
2021-0902.92
2021-1002.27
2021-1104.24
2021-1202.72
2022-0102.54
2022-0203.16
2022-0303.32
2022-0402.45
2022-0503.91
2022-0604.21
2022-0703.33
2022-0802.9
2022-0902.32
2022-1003.76
2022-1103.44
2022-1204.22
2023-0103.18
2023-0203.44
2023-0303.77
2023-0403.26
2023-0503.02
2023-0602.6
2023-0702.69
2023-0802.51
2023-0904.04
2023-1003.21
2023-1109.13
2023-1204
2024-0103.71
2024-0204.15
2024-0304.4
2024-0403.95
2024-0504.89
2024-0604.54
2024-0703.92
2024-0804.59
2024-0904.53
2024-1006.31
2024-1104.74
2024-1204.01
2025-0108.37
2025-0204.23
2025-0303.59
2025-0404.2
2025-0504.57
2025-0604.14
2025-0704.32
2025-0805.03
2025-0903.85
2025-1003.97
2025-1104.12
2025-1204.59
2026-0104.53
2026-0204.25
2026-0304.08
2026-0403.9
2026-0504.99
2026-0603.99
This device (reports/month)Average device in OLO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K253381 — cites (transitively): K162309 (d1), K251282 (d1), K251316 (d1), K050438 (d2), K133444 (d2), K153660 (d2), K201189 (d2), K220593 (d2), K131425 (d2), K150231 (d2), K160713 (d2), K163581 (d2), K172199 (d2), K182104 (d2), K182121 (d2), K183644 (d2), K201267 (d2), K202552 (d2), K211441 (d2), K211596 (d2), K212005 (d2), K212524 (d2), K214011 (d2), K222383 (d2), K230064 (d2), K231184 (d2), K232141 (d2), K233951 (d2), K241605 (d2), K073291 (d3), K083026 (d3), K103731 (d3), K112405 (d3), K124004 (d3), K140454 (d3), K150216 (d3), K992927 (d3), K081475 (d3), K090112 (d3), K143628 (d3), K142559 (d3), K094025 (d3), K110543 (d3), K133205 (d3), K151128 (d3), K170011 (d3), K171267 (d3), K111520 (d3), K153442 (d3), K163221 (d3), K183515 (d3), K123027 (d3), K171689 (d3), K190959 (d3), K191581 (d3), K192336 (d3), K203005 (d3), K201327 (d3), K091813 (d3), K100175 (d3), K113528 (d3), K120368 (d3), K150135 (d3), K152277 (d3), K172328 (d3), K180091 (d3), K123047 (d3), K132897 (d3), K133577 (d3), K210425 (d3), K211258 (d3), K123270 (d3), K182077 (d3), K162341 (d3), K172034 (d3), K230593 (d3), K221180 (d3), K201362 (d3), K221244 (d3), K210637 (d3), K223494 (d3), K172009 (d3), K190165 (d3), K191822 (d3), P960025 (d3), K052261 (d4), P950019 (d4), K061113 (d4), K061639 (d4), K063305 (d4), K090353 (d4), K033926 (d4), K071795 (d4), K082732 (d4), K053008 (d4), K954451 (d4), K122037 (d4), K122591 (d4), K072970 (d4), K083626 (d4), K102293 (d4), K113447 (d4), K121333 (d4), K071416 (d4), K100043 (d4), K123045 (d4), K131669 (d4), K133650 (d4), K142450 (d4), K991460 (d4), P970015 (d4), K130177 (d4), K091442 (d4), K050439 (d4), K102555 (d4), K113174 (d4), K121020 (d4), K152457 (d4), K153240 (d4), K111019 (d4), K152041 (d4), K121332 (d4), K160547 (d4), K162358 (d4), K141665 (d4), K162264 (d4), K012380 (d4), K141941 (d4), K162212 (d4), K162680 (d4), K170592 (d4), K083810 (d4), K141669 (d4), K163595 (d4), K170172 (d4), K180307 (d4), K163182 (d4), K163565 (d4), K170312 (d4), K171107 (d4), K073109 (d4), K080615 (d4), K140055 (d4), K142589 (d4), K163269 (d4), K170399 (d4), K173535 (d4), K183557 (d4), K192018 (d4), K091088 (d4), K110442 (d4), K140280 (d4), K160874 (d4), K161485 (d4), K171312 (d4), K173324 (d4), K191039 (d4), K042025 (d4), K122433 (d4), K152604 (d4), K170679 (d4), K180700 (d4), K191148 (d4), K193011 (d4), K200935 (d4), K133216 (d4), K171031 (d4), K061591 (d4), K201407 (d4), K203291 (d4), K203678 (d4), K201605 (d4), K203201 (d4), K091974 (d4), K132471 (d4), K141604 (d4), K150178 (d4), K162379 (d4), K214010 (d4), K221646 (d4), K173112 (d4), K093242 (d5), K072791 (d5), K073202 (d5), K080401 (d5), K080537 (d5), K081730 (d5), K100214 (d5), K073714 (d5), K102701 (d5), K111571 (d5), K030327 (d5), K073285 (d5), K094042 (d5), K690353 (d5), K091445 (d5), K121760 (d5), K102067 (d5), K081614 (d5), K043488 (d5), K121680 (d5), K132111 (d5), K080699 (d5), K090816 (d5), K113348 (d5), K120918 (d5), K123231 (d5), K130820 (d5), K131082 (d5), K132601 (d5), K133455 (d5), K140319 (d5), K022579 (d5), K131214 (d5), K140417 (d5), K032812 (d5), K083714 (d5), K100889 (d5), K111626 (d5), K132328 (d5), K142591 (d5), K120812 (d5), K140167 (d5), K142847 (d5), K150460 (d5), K130874 (d5), K141551 (d5), K150301 (d5), K082698 (d5), K110843 (d5), K130699 (d5), K150481 (d5), K090064 (d5), K133614 (d5), K160125 (d5), K100089 (d5), K150673 (d5), K151276 (d5), K151773 (d5), K160051 (d5), K031833 (d5), K121982 (d5), K020069 (d5), K072315 (d5), K870157 (d5), K141953 (d5), K072226 (d5), K083798 (d5), K151214 (d5), K012457 (d5), K121264 (d5), K113529 (d5), K122862 (d5), K132639 (d5), K141494 (d5), K143019 (d5), K143375 (d5), K153463 (d5), K132053 (d5), K050579 (d5), K102913 (d5), K934828 (d5), K982518 (d5), K142026 (d5), K160154 (d5), K163491 (d5), K148529 (d5), K151596 (d5), K153122 (d5), K160983 (d5), K163032 (d5), K170676 (d5), K171686 (d5), K172676 (d5), K180364 (d5), K173125 (d5), K170347 (d5), K171938 (d5), K182119 (d5), K130646 (d5), K172888 (d5), K181644 (d5), K183447 (d5), K153419 (d5), K161230 (d5), K170962 (d5), K172341 (d5), K173153 (d5), K181386 (d5), K181860 (d5), K192760 (d5), K193541 (d5), K193593 (d5), K200953 (d5), K201820 (d5), K140449 (d5), K182928 (d5), K022191 (d5), K030875 (d5), K140750 (d5), K150200 (d5), K191066 (d5), K954645 (d5), K092336 (d6), P000028 (d6), P980048 (d6), K082801 (d6), P950002 (d6), K090648 (d6), K051454 (d6), K063399 (d6), K080024 (d6), K011182 (d6), K070387 (d6), K073562 (d6), K080313 (d6), K102249 (d6), K031635 (d6), K080568 (d6), K081917 (d6), K101923 (d6), K110911 (d6), K113228 (d6), K081277 (d6), K031672 (d6), K103169 (d6), K002732 (d6), K023570 (d6), K062933 (d6), K082310 (d6), K091278 (d6), K092193 (d6), K100042 (d6), K062640 (d6), K131321 (d6), K090390 (d6), K101074 (d6), K981676 (d6), K130548 (d6), K052747 (d6), K043206 (d6), K133623 (d6), K101302 (d6), K110632 (d6), K122967 (d6), K100967 (d6), K132584 (d6), K140276 (d6), K110733 (d6), K113518 (d6), K031655 (d6), K052187 (d6), K141605 (d6), K133904 (d6), K130784 (d6), K093828 (d6), K102397 (d6), K100945 (d6), K112316 (d6), K113138 (d6), K113561 (d6), K141405 (d6), K072253 (d6), K072981 (d6), K122639 (d6), K131276 (d6), K141942 (d6), K142940 (d6), K140759 (d6), K143163 (d6), K150994 (d6), K151472 (d6), K131723 (d6), K140479 (d6), K072991 (d6), K133494 (d6), K150362 (d6), K152304 (d6), K073351 (d6), K151227 (d6), K141896 (d6), K153782 (d6), K113164 (d6), K120570 (d6), K153107 (d6), K162103 (d6), K163230 (d6), K171633 (d6), K081611 (d6), K120603 (d6), K140003 (d6), K162138 (d6), K170503 (d6), K052931 (d6), K071033 (d6), K083186 (d6), K100976 (d6), K163506 (d6), K120275 (d6), K171496 (d6), K161888 (d6), K140348 (d6), K020709 (d6), K042790 (d6), K050809 (d6), K052609 (d6), K061915 (d6), K181014 (d6), K183510 (d6), K172123 (d6), K152943 (d6), K153105 (d6), K003836 (d7), K010930 (d7), K033801 (d7), K041584 (d7), K043479 (d7), K082112 (d7), K091883 (d7), K040962 (d7), K050981 (d7), K062174 (d7), K071724 (d7), K073348 (d7), K082260 (d7), K083894 (d7), K063736 (d7), K022414 (d7), K050553 (d7), K072465 (d7), K091426 (d7), K111123 (d7), K090507 (d7), K092901 (d7), K043528 (d7), K103382 (d7), K132594 (d7), K092211 (d7), K120031 (d7), K122630 (d7), K123206 (d7), K111457 (d7), K123969 (d7), K132738 (d7), K133126 (d7), K133340 (d7), K001340 (d7), K023835 (d7), K030833 (d7), K052746 (d7), K073649 (d7), K082128 (d7), K110454 (d7), K110694 (d7), K081968 (d7), K131372 (d7), K140659 (d7), K101301 (d7), K101310 (d7), K102090 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K072415 (d7), K113252 (d7), K113559 (d7), K120819 (d7), K083661 (d7), K093704 (d7), K093864 (d7), K100865 (d7), K101051 (d7), K120869 (d7), K133328 (d7), K141217 (d7), K140921 (d7), K142050 (d7), K142264 (d7), K060506 (d7), K123486 (d7), K132624 (d7), K143393 (d7), K143616 (d7), K140770 (d7), K151374 (d7), K073669 (d7), K100210 (d7), K120991 (d7), K123997 (d7), K140142 (d7), K143740 (d7), K141135 (d7), K153495 (d7), K160916 (d7), K143685 (d7), K151322 (d7), K080588 (d7), K093669 (d7), K112095 (d7), K122588 (d7), K143258 (d7), K101171 (d7), K142251 (d7), K152532 (d7), K160924 (d7), K162262 (d7), K153627 (d7), K143065 (d7), K160955 (d7), K181328 (d7), K082262 (d8), K090166 (d8), K073177 (d8), K090425 (d8), K073470 (d8), K080758 (d8), K082014 (d8), K082252 (d8), K090899 (d8), K062083 (d8), K083475 (d8), K071833 (d8), K080971 (d8), K092070 (d8), K072160 (d8), K080822 (d8), K083447 (d8), K031729 (d8), K040267 (d8), K042883 (d8), K042993 (d8), K051146 (d8), K051380 (d8), K051977 (d8), K053514 (d8), K061521 (d8), K072221 (d8), K072575 (d8), K123166 (d8), K090566 (d8), K121693 (d8), K100305 (d8), K111166 (d8), K062151 (d8), K081888 (d8), K103666 (d8), K133557 (d8), K120486 (d8), K021039 (d8), K040130 (d8), K072339 (d8), K072943 (d8), K090415 (d8), K121837 (d8), K103111 (d8), K053340 (d8), K100391 (d8), K133218 (d8), K140162 (d8), K143126 (d8), K102606 (d8), K142066 (d8), K150053 (d8), K110327 (d8), K113285 (d8), K142645 (d8), K150643 (d8), K152475 (d8), K143595 (d8), K150788 (d8), K151310 (d8), K151726 (d8), K012254 (d8), K151651 (d8), K162315 (d8), K172032 (d8)

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

Manufacturer compliance record — MEDTRONIC NAVIGATION, INC.

  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • VAI 2021-06-29 Medtronic Navigation, Inc. · 3 citations
  • VAI 2019-09-30 Medtronic Navigation, Inc. · 1 citations
  • VAI 2016-08-18 Medtronic Navigation, Inc. · 0 citations
  • NAI 2014-12-15 Medtronic Navigation, Inc. · 0 citations
  • VAI 2014-02-19 Medtronic Navigation, Inc. · 5 citations
  • NAI 2012-09-06 Medtronic Navigation, Inc. · 0 citations
  • NAI 2012-05-01 Medtronic Navigation, Inc. · 0 citations
  • VAI 2011-03-24 Medtronic Navigation, Inc. · 1 citations
  • OAI 2010-02-04 Medtronic Navigation, Inc. · 9 citations