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ASTRA-OCT Spine System

Model A3P-4028 · SPINECRAFT, LLC · DI M824A3P40281

KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050

NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075

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 1.9/device2019-03: 0 reports for this device; peer average 1.9/device2019-04: 0 reports for this device; peer average 2.09/device2019-05: 0 reports for this device; peer average 2.08/device2019-06: 0 reports for this device; peer average 2.2/device2019-07: 0 reports for this device; peer average 1.63/device2019-08: 0 reports for this device; peer average 2.42/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 1.77/device2019-11: 0 reports for this device; peer average 2.07/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 0 reports for this device; peer average 2.69/device2020-02: 0 reports for this device; peer average 2.46/device2020-03: 0 reports for this device; peer average 2.51/device2020-04: 0 reports for this device; peer average 1.44/device2020-05: 0 reports for this device; peer average 2.08/device2020-06: 0 reports for this device; peer average 2.19/device2020-07: 0 reports for this device; peer average 1.69/device2020-08: 0 reports for this device; peer average 1.76/device2020-09: 0 reports for this device; peer average 2.04/device2020-10: 0 reports for this device; peer average 2.3/device2020-11: 0 reports for this device; peer average 2.14/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.05/device2021-02: 0 reports for this device; peer average 1.92/device2021-03: 0 reports for this device; peer average 2.19/device2021-04: 0 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 1.95/device2021-06: 0 reports for this device; peer average 1.94/device2021-07: 0 reports for this device; peer average 8.17/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.29/device2021-11: 0 reports for this device; peer average 1.86/device2021-12: 0 reports for this device; peer average 1.97/device2022-01: 0 reports for this device; peer average 2.03/device2022-02: 0 reports for this device; peer average 1.87/device2022-03: 0 reports for this device; peer average 1.72/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 1.66/device2022-06: 0 reports for this device; peer average 2.06/device2022-07: 0 reports for this device; peer average 2.98/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 2.84/device2022-10: 0 reports for this device; peer average 1.49/device2022-11: 0 reports for this device; peer average 1.83/device2022-12: 0 reports for this device; peer average 1.98/device2023-01: 0 reports for this device; peer average 1.78/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2.04/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 1.61/device2023-07: 0 reports for this device; peer average 1.77/device2023-08: 0 reports for this device; peer average 1.47/device2023-09: 0 reports for this device; peer average 2.61/device2023-10: 0 reports for this device; peer average 2.37/device2023-11: 0 reports for this device; peer average 2.09/device2023-12: 0 reports for this device; peer average 1.55/device2024-01: 0 reports for this device; peer average 2.38/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 3.58/device2024-04: 0 reports for this device; peer average 1.69/device2024-05: 0 reports for this device; peer average 3.28/device2024-06: 0 reports for this device; peer average 2.21/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 2.44/device2024-10: 0 reports for this device; peer average 2.36/device2024-11: 0 reports for this device; peer average 1.85/device2024-12: 0 reports for this device; peer average 1.78/device2025-01: 0 reports for this device; peer average 2.41/device2025-02: 0 reports for this device; peer average 2.37/device2025-03: 0 reports for this device; peer average 2.08/device2025-04: 0 reports for this device; peer average 2.13/device2025-05: 0 reports for this device; peer average 2.42/device2025-06: 0 reports for this device; peer average 2.59/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.92/device2025-09: 0 reports for this device; peer average 1.89/device2025-10: 0 reports for this device; peer average 1.98/device2025-11: 0 reports for this device; peer average 1.99/device2025-12: 0 reports for this device; peer average 2.3/device2026-01: 0 reports for this device; peer average 2.53/device2026-02: 0 reports for this device; peer average 2.41/device2026-03: 0 reports for this device; peer average 2.43/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 2.34/device2026-06: 0 reports for this device; peer average 4.01/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
2019-0201.9
2019-0301.9
2019-0402.09
2019-0502.08
2019-0602.2
2019-0701.63
2019-0802.42
2019-0901.86
2019-1001.77
2019-1102.07
2019-1201.55
2020-0102.69
2020-0202.46
2020-0302.51
2020-0401.44
2020-0502.08
2020-0602.19
2020-0701.69
2020-0801.76
2020-0902.04
2020-1002.3
2020-1102.14
2020-1202.07
2021-0102.05
2021-0201.92
2021-0302.19
2021-0402.02
2021-0501.95
2021-0601.94
2021-0708.17
2021-0802
2021-0901.72
2021-1002.29
2021-1101.86
2021-1201.97
2022-0102.03
2022-0201.87
2022-0301.72
2022-0401.76
2022-0501.66
2022-0602.06
2022-0702.98
2022-0802.07
2022-0902.84
2022-1001.49
2022-1101.83
2022-1201.98
2023-0101.78
2023-0201.96
2023-0302
2023-0402.04
2023-0502.02
2023-0601.61
2023-0701.77
2023-0801.47
2023-0902.61
2023-1002.37
2023-1102.09
2023-1201.55
2024-0102.38
2024-0202.08
2024-0303.58
2024-0401.69
2024-0503.28
2024-0602.21
2024-0701.9
2024-0801.83
2024-0902.44
2024-1002.36
2024-1101.85
2024-1201.78
2025-0102.41
2025-0202.37
2025-0302.08
2025-0402.13
2025-0502.42
2025-0602.59
2025-0701.83
2025-0801.92
2025-0901.89
2025-1001.98
2025-1101.99
2025-1202.3
2026-0102.53
2026-0202.41
2026-0302.43
2026-0401.8
2026-0502.34
2026-0604.01
This device (reports/month)Average device in KWP, NKG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K181350 — cites (transitively): K013222 (d1), K022190 (d1), K030103 (d1), K041203 (d1), K042508 (d1), K080828 (d1), K090549 (d1), K090714 (d1), K091365 (d1), K093434 (d1), K103100 (d1), K110353 (d1), K110522 (d1), K123656 (d1), K132122 (d1), K132332 (d1), K133698 (d1), K141897 (d1), K142838 (d1), K143471 (d1), K143628 (d1), K143683 (d1), K150552 (d1), K151885 (d1), K954696 (d1), K003780 (d2), K062447 (d2), K070742 (d2), K082728 (d2), K083071 (d2), K042789 (d2), K080805 (d2), K061943 (d2), K033961 (d2), K062934 (d2), K080526 (d2), K023675 (d2), K030377 (d2), K091689 (d2), K062254 (d2), K123568 (d2), K123906 (d2), K140454 (d2), K000536 (d2), K060748 (d2), K062513 (d2), K071373 (d2), K081252 (d2), K090648 (d2), K092825 (d2), K102488 (d2), K102701 (d2), K110906 (d2), K113666 (d2), K132603 (d2), K142185 (d2), K940631 (d2), K950099 (d2), K950697 (d2), K980288 (d2), K050391 (d2), K081906 (d2), K090565 (d2), K110963 (d2), K123783 (d2), K013296 (d3), K024348 (d3), K080792 (d3), K100788 (d3), K102288 (d3), K052123 (d3), K100409 (d3), K100438 (d3), K103393 (d3), K023555 (d3), K062728 (d3), K061202 (d3), K080394 (d3), K122226 (d3), K121191 (d3), K093294 (d3), K124004 (d3), K033901 (d3), K070387 (d3), K091994 (d3), K111136 (d3), K090523 (d4), K934429 (d4), K073172 (d4), K093058 (d4), K100220 (d4), K082572 (d4), K050438 (d4), K090203 (d5) — cited as predicate by K223301

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

Manufacturer compliance record — SPINECRAFT, LLC

  • VAI 2024-03-22 SpineCraft, LLC. · 2 citations
  • VAI 2024-03-22 SpineCraft, LLC. · 2 citations
  • NAI 2018-12-13 SpineCraft, LLC. · 0 citations
  • NAI 2018-12-13 SpineCraft, LLC. · 0 citations
  • NAI 2016-08-18 SpineCraft, LLC. · 0 citations
  • NAI 2016-08-18 SpineCraft, LLC. · 0 citations
  • NAI 2012-04-12 SpineCraft, LLC. · 0 citations
  • NAI 2012-04-12 SpineCraft, LLC. · 0 citations