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Polyaxial Screw, 4.9 x 40

Model 2412-4940 · CAPTIVA SPINE, INC. · DI M73924124940

MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070

MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070

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.

24682019-01: 0 reports for this device; peer average 2.08/device2019-02: 0 reports for this device; peer average 1.89/device2019-03: 0 reports for this device; peer average 2.06/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2.31/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 2.87/device2019-09: 0 reports for this device; peer average 1.72/device2019-10: 0 reports for this device; peer average 1.87/device2019-11: 0 reports for this device; peer average 2.24/device2019-12: 0 reports for this device; peer average 1.69/device2020-01: 0 reports for this device; peer average 2.37/device2020-02: 0 reports for this device; peer average 2.2/device2020-03: 0 reports for this device; peer average 2.08/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 2.29/device2020-06: 0 reports for this device; peer average 1.87/device2020-07: 0 reports for this device; peer average 1.8/device2020-08: 0 reports for this device; peer average 1.92/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 2.57/device2020-11: 0 reports for this device; peer average 2.36/device2020-12: 0 reports for this device; peer average 2.05/device2021-01: 0 reports for this device; peer average 2.26/device2021-02: 0 reports for this device; peer average 1.86/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 2.31/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1.72/device2021-07: 0 reports for this device; peer average 7.73/device2021-08: 0 reports for this device; peer average 1.94/device2021-09: 0 reports for this device; peer average 1.68/device2021-10: 0 reports for this device; peer average 2.66/device2021-11: 0 reports for this device; peer average 2.37/device2021-12: 0 reports for this device; peer average 2.38/device2022-01: 0 reports for this device; peer average 2.15/device2022-02: 0 reports for this device; peer average 1.9/device2022-03: 0 reports for this device; peer average 1.89/device2022-04: 0 reports for this device; peer average 2.13/device2022-05: 0 reports for this device; peer average 1.8/device2022-06: 0 reports for this device; peer average 1.99/device2022-07: 0 reports for this device; peer average 3.89/device2022-08: 0 reports for this device; peer average 1.91/device2022-09: 0 reports for this device; peer average 2.75/device2022-10: 0 reports for this device; peer average 1.4/device2022-11: 0 reports for this device; peer average 1.96/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 1.61/device2023-02: 0 reports for this device; peer average 1.73/device2023-03: 0 reports for this device; peer average 1.88/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1.55/device2023-06: 0 reports for this device; peer average 1.78/device2023-07: 0 reports for this device; peer average 1.93/device2023-08: 0 reports for this device; peer average 1.49/device2023-09: 0 reports for this device; peer average 2.9/device2023-10: 0 reports for this device; peer average 2.86/device2023-11: 0 reports for this device; peer average 2.87/device2023-12: 0 reports for this device; peer average 1.68/device2024-01: 0 reports for this device; peer average 2.5/device2024-02: 0 reports for this device; peer average 2.15/device2024-03: 0 reports for this device; peer average 3.98/device2024-04: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 3.43/device2024-06: 0 reports for this device; peer average 1.63/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 1.96/device2024-10: 0 reports for this device; peer average 1.77/device2024-11: 0 reports for this device; peer average 2.39/device2024-12: 0 reports for this device; peer average 1.72/device2025-01: 0 reports for this device; peer average 2.18/device2025-02: 0 reports for this device; peer average 2.41/device2025-03: 0 reports for this device; peer average 2.5/device2025-04: 0 reports for this device; peer average 2.45/device2025-05: 0 reports for this device; peer average 1.84/device2025-06: 0 reports for this device; peer average 1.81/device2025-07: 0 reports for this device; peer average 2.26/device2025-08: 0 reports for this device; peer average 1.82/device2025-09: 0 reports for this device; peer average 1.94/device2025-10: 0 reports for this device; peer average 2.1/device2025-11: 0 reports for this device; peer average 1.92/device2025-12: 0 reports for this device; peer average 2.18/device2026-01: 0 reports for this device; peer average 2.54/device2026-02: 0 reports for this device; peer average 2.46/device2026-03: 0 reports for this device; peer average 2.64/device2026-04: 0 reports for this device; peer average 1.84/device2026-05: 0 reports for this device; peer average 1.63/device2026-06: 0 reports for this device; peer average 5.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.08
2019-0201.89
2019-0302.06
2019-0402
2019-0502.31
2019-0602.72
2019-0701.69
2019-0802.87
2019-0901.72
2019-1001.87
2019-1102.24
2019-1201.69
2020-0102.37
2020-0202.2
2020-0302.08
2020-0401.67
2020-0502.29
2020-0601.87
2020-0701.8
2020-0801.92
2020-0902.5
2020-1002.57
2020-1102.36
2020-1202.05
2021-0102.26
2021-0201.86
2021-0302.5
2021-0402.31
2021-0502
2021-0601.72
2021-0707.73
2021-0801.94
2021-0901.68
2021-1002.66
2021-1102.37
2021-1202.38
2022-0102.15
2022-0201.9
2022-0301.89
2022-0402.13
2022-0501.8
2022-0601.99
2022-0703.89
2022-0801.91
2022-0902.75
2022-1001.4
2022-1101.96
2022-1202.04
2023-0101.61
2023-0201.73
2023-0301.88
2023-0402
2023-0501.55
2023-0601.78
2023-0701.93
2023-0801.49
2023-0902.9
2023-1002.86
2023-1102.87
2023-1201.68
2024-0102.5
2024-0202.15
2024-0303.98
2024-0401.8
2024-0503.43
2024-0601.63
2024-0701.9
2024-0802.14
2024-0901.96
2024-1001.77
2024-1102.39
2024-1201.72
2025-0102.18
2025-0202.41
2025-0302.5
2025-0402.45
2025-0501.84
2025-0601.81
2025-0702.26
2025-0801.82
2025-0901.94
2025-1002.1
2025-1101.92
2025-1202.18
2026-0102.54
2026-0202.46
2026-0302.64
2026-0401.84
2026-0501.63
2026-0605.13
This device (reports/month)Average device in MNH, MNI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K120292 — cited as predicate by K131538

K131538 — cites (transitively): K120292 (d1), K121020 (d1), K102701 (d2), K111571 (d2), K090648 (d3), K011182 (d3), K070387 (d3), K073562 (d3), K080313 (d3), K102249 (d3), K062174 (d4) — cited as predicate by K151116, K180475, K193270

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

Manufacturer compliance record — CAPTIVA SPINE, INC.

  • NAI 2025-01-14 Captiva Spine, Inc · 0 citations
  • NAI 2025-01-14 Captiva Spine, Inc · 0 citations
  • VAI 2017-02-17 Captiva Spine, Inc · 3 citations
  • VAI 2017-02-17 Captiva Spine, Inc · 3 citations
  • VAI 2013-01-16 Captiva Spine, Inc · 2 citations
  • VAI 2013-01-16 Captiva Spine, Inc · 2 citations
  • VAI 2012-03-09 Captiva Spine, Inc · 8 citations
  • VAI 2012-03-09 Captiva Spine, Inc · 8 citations