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Invictus

Model 17950-N · ALPHATEC SPINE, INC. · DI 00190376475202

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

UDILibrary device dossier · generated 2026-09-12 · 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 (67)

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.

Malfunction: 63 · Injury: 4

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: 4 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 8 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: 1 reports for this device; peer average 4.2/device2025-05: 2 reports for this device; peer average 4.57/device2025-06: 3 reports for this device; peer average 4.14/device2025-07: 2 reports for this device; peer average 4.32/device2025-08: 4 reports for this device; peer average 5.03/device2025-09: 3 reports for this device; peer average 3.85/device2025-10: 6 reports for this device; peer average 3.97/device2025-11: 6 reports for this device; peer average 4.12/device2025-12: 6 reports for this device; peer average 4.59/device2026-01: 6 reports for this device; peer average 4.53/device2026-02: 2 reports for this device; peer average 4.25/device2026-03: 6 reports for this device; peer average 4.08/device2026-04: 4 reports for this device; peer average 3.9/device2026-05: 2 reports for this device; peer average 4.99/device2026-06: 2 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
2024-1144.74
2024-1204.01
2025-0188.37
2025-0204.23
2025-0303.59
2025-0414.2
2025-0524.57
2025-0634.14
2025-0724.32
2025-0845.03
2025-0933.85
2025-1063.97
2025-1164.12
2025-1264.59
2026-0164.53
2026-0224.25
2026-0364.08
2026-0443.9
2026-0524.99
2026-0623.99
This device (reports/month)Average device in OLO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K153603 — cites (transitively): K123623 (d1), K133221 (d1), K140454 (d1), K143149 (d1), K152968 (d1), K033090 (d2), K042673 (d2), K071890 (d2), K124004 (d2), K100685 (d2), K013440 (d2), K142591 (d2), K142798 (d2), K050438 (d3), K031655 (d3), K042025 (d3), K052187 (d3), K141494 (d3), K123138 (d3), K091974 (d4), K140276 (d4), K091445 (d5), K111457 (d5), K132328 (d5), K132471 (d5), K050439 (d6), K090390 (d6), K101074 (d6), K981676 (d6), K040962 (d7), K050981 (d7) — cited as predicate by K172517, K172623, K182731, K223808

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

Manufacturer compliance record — ALPHATEC SPINE, INC.

  • Warning Letter 2015-07-16 Alphatec Spine, Inc.
  • Warning Letter 2011-01-11 Alphatec Spine, Inc.
  • Warning Letter 2010-06-21 Alphatec Spine, Inc.
  • VAI 2017-04-19 Alphatec Spine, Inc. · 1 citations
  • VAI 2016-03-16 Alphatec Spine, Inc. · 1 citations
  • OAI 2015-03-13 Alphatec Spine, Inc. · 0 citations
  • NAI 2013-06-14 Alphatec Spine, Inc. · 0 citations
  • VAI 2012-04-27 Alphatec Spine, Inc. · 0 citations
  • VAI 2010-12-13 Alphatec Spine, Inc. · 7 citations
  • OAI 2010-02-11 Alphatec Spine, Inc. · 11 citations