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Simpact

Model 152-14-960 · Life Spine, Inc. · DI 00190837119072

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

OUR — Sacroiliac Joint Fixation · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-10 · 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.

13452019-01: 0 reports for this device; peer average 2.15/device2019-02: 0 reports for this device; peer average 1.63/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 2.22/device2019-05: 0 reports for this device; peer average 1.77/device2019-06: 0 reports for this device; peer average 1.82/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 2.04/device2019-09: 0 reports for this device; peer average 1.76/device2019-10: 0 reports for this device; peer average 1.74/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.49/device2020-01: 0 reports for this device; peer average 2.54/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 1.89/device2020-04: 0 reports for this device; peer average 1.86/device2020-05: 0 reports for this device; peer average 1.79/device2020-06: 0 reports for this device; peer average 2.07/device2020-07: 0 reports for this device; peer average 2.68/device2020-08: 0 reports for this device; peer average 2.48/device2020-09: 0 reports for this device; peer average 2.45/device2020-10: 0 reports for this device; peer average 2.23/device2020-11: 0 reports for this device; peer average 2.79/device2020-12: 0 reports for this device; peer average 2.46/device2021-01: 0 reports for this device; peer average 1.85/device2021-02: 0 reports for this device; peer average 2.3/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 0 reports for this device; peer average 2.63/device2021-05: 0 reports for this device; peer average 2.4/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 0 reports for this device; peer average 2.28/device2021-08: 0 reports for this device; peer average 2.13/device2021-09: 0 reports for this device; peer average 2.34/device2021-10: 0 reports for this device; peer average 2.02/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 2.33/device2022-01: 0 reports for this device; peer average 2.88/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 2.02/device2022-04: 0 reports for this device; peer average 1.94/device2022-05: 0 reports for this device; peer average 2.38/device2022-06: 0 reports for this device; peer average 2.22/device2022-07: 0 reports for this device; peer average 2.17/device2022-08: 0 reports for this device; peer average 2.48/device2022-09: 0 reports for this device; peer average 2.88/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 2.99/device2022-12: 0 reports for this device; peer average 5.47/device2023-01: 0 reports for this device; peer average 2.72/device2023-02: 0 reports for this device; peer average 2.85/device2023-03: 0 reports for this device; peer average 3.08/device2023-04: 0 reports for this device; peer average 2.76/device2023-05: 0 reports for this device; peer average 3.3/device2023-06: 0 reports for this device; peer average 2.94/device2023-07: 0 reports for this device; peer average 2.27/device2023-08: 0 reports for this device; peer average 2.15/device2023-09: 0 reports for this device; peer average 2.02/device2023-10: 0 reports for this device; peer average 2.14/device2023-11: 0 reports for this device; peer average 1.87/device2023-12: 0 reports for this device; peer average 2.44/device2024-01: 0 reports for this device; peer average 2.76/device2024-02: 0 reports for this device; peer average 1.8/device2024-03: 0 reports for this device; peer average 2.33/device2024-04: 0 reports for this device; peer average 2.12/device2024-05: 0 reports for this device; peer average 2.28/device2024-06: 0 reports for this device; peer average 2.26/device2024-07: 0 reports for this device; peer average 2.46/device2024-08: 0 reports for this device; peer average 2.12/device2024-09: 0 reports for this device; peer average 2.15/device2024-10: 0 reports for this device; peer average 2.19/device2024-11: 0 reports for this device; peer average 2.05/device2024-12: 0 reports for this device; peer average 2.75/device2025-01: 0 reports for this device; peer average 2.2/device2025-02: 0 reports for this device; peer average 2.25/device2025-03: 0 reports for this device; peer average 2.06/device2025-04: 0 reports for this device; peer average 2.54/device2025-05: 0 reports for this device; peer average 2.49/device2025-06: 0 reports for this device; peer average 2.01/device2025-07: 0 reports for this device; peer average 2.13/device2025-08: 0 reports for this device; peer average 2.39/device2025-09: 0 reports for this device; peer average 2.06/device2025-10: 0 reports for this device; peer average 2.55/device2025-11: 0 reports for this device; peer average 2.04/device2025-12: 0 reports for this device; peer average 2.73/device2026-01: 0 reports for this device; peer average 2.06/device2026-02: 0 reports for this device; peer average 2.35/device2026-03: 0 reports for this device; peer average 2.61/device2026-04: 0 reports for this device; peer average 2.17/device2026-05: 0 reports for this device; peer average 2.56/device2026-06: 0 reports for this device; peer average 2.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.15
2019-0201.63
2019-0301.68
2019-0402.22
2019-0501.77
2019-0601.82
2019-0702.06
2019-0802.04
2019-0901.76
2019-1001.74
2019-1101.96
2019-1202.49
2020-0102.54
2020-0202.18
2020-0301.89
2020-0401.86
2020-0501.79
2020-0602.07
2020-0702.68
2020-0802.48
2020-0902.45
2020-1002.23
2020-1102.79
2020-1202.46
2021-0101.85
2021-0202.3
2021-0302.59
2021-0402.63
2021-0502.4
2021-0602.18
2021-0702.28
2021-0802.13
2021-0902.34
2021-1002.02
2021-1102.25
2021-1202.33
2022-0102.88
2022-0202.2
2022-0302.02
2022-0401.94
2022-0502.38
2022-0602.22
2022-0702.17
2022-0802.48
2022-0902.88
2022-1003
2022-1102.99
2022-1205.47
2023-0102.72
2023-0202.85
2023-0303.08
2023-0402.76
2023-0503.3
2023-0602.94
2023-0702.27
2023-0802.15
2023-0902.02
2023-1002.14
2023-1101.87
2023-1202.44
2024-0102.76
2024-0201.8
2024-0302.33
2024-0402.12
2024-0502.28
2024-0602.26
2024-0702.46
2024-0802.12
2024-0902.15
2024-1002.19
2024-1102.05
2024-1202.75
2025-0102.2
2025-0202.25
2025-0302.06
2025-0402.54
2025-0502.49
2025-0602.01
2025-0702.13
2025-0802.39
2025-0902.06
2025-1002.55
2025-1102.04
2025-1202.73
2026-0102.06
2026-0202.35
2026-0302.61
2026-0402.17
2026-0502.56
2026-0602.32
This device (reports/month)Average device in HWC, OUR (reports/device/month)

Regulatory clearances

  • K201538 SESE 2020-09-18 (k number procode)

Predicate lineage

K201538 — cites (transitively): K141246 (d1), K141549 (d1), K180749 (d1), K193524 (d1), K112028 (d2), K021932 (d2), K102903 (d2), K130092 (d2), K080298 (d2), K080398 (d2), K092375 (d2), K110838 (d2), K190230 (d2), K182983 (d3), K121020 (d4), K162733 (d4), K102701 (d5), K111571 (d5), K150017 (d5), K160652 (d5), K090648 (d6), K011182 (d6), K070387 (d6), K073562 (d6), K080313 (d6), K102249 (d6), K122074 (d6), K123850 (d6), K131405 (d6), K141049 (d6), K150714 (d6), K150875 (d6), K151718 (d6), K152681 (d6), K062174 (d7) — cited as predicate by K203780, K212903, K241464, K253611, K260571

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

Manufacturer compliance record — Life Spine, Inc.

  • VAI 2025-05-02 Life Spine, Inc. · 2 citations
  • VAI 2025-05-02 Life Spine, Inc. · 2 citations
  • NAI 2014-06-30 Life Spine, Inc. · 0 citations
  • NAI 2014-06-30 Life Spine, Inc. · 0 citations
  • NAI 2010-11-09 Life Spine, Inc. · 0 citations
  • NAI 2010-11-09 Life Spine, Inc. · 0 citations