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SafeOp

Model AIX11901 · ALPHATEC SPINE, INC. · DI 00190376330723

ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820

GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870

IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375

PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820

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 (18)

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: 12 · Injury: 6

4913172019-01: 0 reports for this device; peer average 3.02/device2019-02: 0 reports for this device; peer average 3.8/device2019-03: 0 reports for this device; peer average 3.07/device2019-04: 0 reports for this device; peer average 1.84/device2019-05: 0 reports for this device; peer average 2.02/device2019-06: 0 reports for this device; peer average 1.56/device2019-07: 0 reports for this device; peer average 1.72/device2019-08: 0 reports for this device; peer average 4.08/device2019-09: 0 reports for this device; peer average 2.75/device2019-10: 0 reports for this device; peer average 4.2/device2019-11: 0 reports for this device; peer average 4.43/device2019-12: 0 reports for this device; peer average 4.68/device2020-01: 0 reports for this device; peer average 3.33/device2020-02: 0 reports for this device; peer average 2.1/device2020-03: 0 reports for this device; peer average 3.9/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.48/device2020-06: 0 reports for this device; peer average 1.69/device2020-07: 0 reports for this device; peer average 2.68/device2020-08: 0 reports for this device; peer average 2.92/device2020-09: 0 reports for this device; peer average 2.89/device2020-10: 0 reports for this device; peer average 4.06/device2020-11: 0 reports for this device; peer average 2.7/device2020-12: 0 reports for this device; peer average 2.89/device2021-01: 0 reports for this device; peer average 1.16/device2021-02: 0 reports for this device; peer average 2.22/device2021-03: 0 reports for this device; peer average 1.84/device2021-04: 0 reports for this device; peer average 1.97/device2021-05: 0 reports for this device; peer average 1.68/device2021-06: 0 reports for this device; peer average 2.28/device2021-07: 0 reports for this device; peer average 3.03/device2021-08: 0 reports for this device; peer average 2.28/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 2.79/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1.59/device2022-01: 0 reports for this device; peer average 2.18/device2022-02: 0 reports for this device; peer average 1.95/device2022-03: 0 reports for this device; peer average 1.48/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 2 reports for this device; peer average 2.7/device2022-06: 0 reports for this device; peer average 2.17/device2022-07: 0 reports for this device; peer average 1.83/device2022-08: 0 reports for this device; peer average 2.12/device2022-09: 0 reports for this device; peer average 2.06/device2022-10: 0 reports for this device; peer average 2.52/device2022-11: 4 reports for this device; peer average 2.26/device2022-12: 0 reports for this device; peer average 2.09/device2023-01: 0 reports for this device; peer average 2.68/device2023-02: 0 reports for this device; peer average 2.11/device2023-03: 2 reports for this device; peer average 2.35/device2023-04: 0 reports for this device; peer average 1.65/device2023-05: 0 reports for this device; peer average 2.34/device2023-06: 0 reports for this device; peer average 2.05/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 2.82/device2023-09: 0 reports for this device; peer average 3.4/device2023-10: 0 reports for this device; peer average 6.86/device2023-11: 0 reports for this device; peer average 5.92/device2023-12: 0 reports for this device; peer average 7.38/device2024-01: 2 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 6.15/device2024-03: 0 reports for this device; peer average 6.35/device2024-04: 0 reports for this device; peer average 8.9/device2024-05: 0 reports for this device; peer average 8.71/device2024-06: 0 reports for this device; peer average 6.63/device2024-07: 0 reports for this device; peer average 10.21/device2024-08: 0 reports for this device; peer average 12.34/device2024-09: 0 reports for this device; peer average 17.49/device2024-10: 0 reports for this device; peer average 13.78/device2024-11: 0 reports for this device; peer average 12.6/device2024-12: 0 reports for this device; peer average 9.08/device2025-01: 0 reports for this device; peer average 8.76/device2025-02: 0 reports for this device; peer average 14.62/device2025-03: 0 reports for this device; peer average 13.68/device2025-04: 0 reports for this device; peer average 10.64/device2025-05: 0 reports for this device; peer average 8.37/device2025-06: 0 reports for this device; peer average 9.62/device2025-07: 0 reports for this device; peer average 16.06/device2025-08: 0 reports for this device; peer average 9.05/device2025-09: 0 reports for this device; peer average 10.32/device2025-10: 0 reports for this device; peer average 15.2/device2025-11: 0 reports for this device; peer average 13.17/device2025-12: 2 reports for this device; peer average 11.91/device2026-01: 4 reports for this device; peer average 9.37/device2026-02: 2 reports for this device; peer average 9.14/device2026-03: 0 reports for this device; peer average 11.44/device2026-04: 0 reports for this device; peer average 11.39/device2026-05: 0 reports for this device; peer average 12.38/device2026-06: 0 reports for this device; peer average 13.23/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.02
2019-0203.8
2019-0303.07
2019-0401.84
2019-0502.02
2019-0601.56
2019-0701.72
2019-0804.08
2019-0902.75
2019-1004.2
2019-1104.43
2019-1204.68
2020-0103.33
2020-0202.1
2020-0303.9
2020-0402.54
2020-0501.48
2020-0601.69
2020-0702.68
2020-0802.92
2020-0902.89
2020-1004.06
2020-1102.7
2020-1202.89
2021-0101.16
2021-0202.22
2021-0301.84
2021-0401.97
2021-0501.68
2021-0602.28
2021-0703.03
2021-0802.28
2021-0904
2021-1002.79
2021-1102
2021-1201.59
2022-0102.18
2022-0201.95
2022-0301.48
2022-0402.5
2022-0522.7
2022-0602.17
2022-0701.83
2022-0802.12
2022-0902.06
2022-1002.52
2022-1142.26
2022-1202.09
2023-0102.68
2023-0202.11
2023-0322.35
2023-0401.65
2023-0502.34
2023-0602.05
2023-0701.75
2023-0802.82
2023-0903.4
2023-1006.86
2023-1105.92
2023-1207.38
2024-0125
2024-0206.15
2024-0306.35
2024-0408.9
2024-0508.71
2024-0606.63
2024-07010.21
2024-08012.34
2024-09017.49
2024-10013.78
2024-11012.6
2024-1209.08
2025-0108.76
2025-02014.62
2025-03013.68
2025-04010.64
2025-0508.37
2025-0609.62
2025-07016.06
2025-0809.05
2025-09010.32
2025-10015.2
2025-11013.17
2025-12211.91
2026-0149.37
2026-0229.14
2026-03011.44
2026-04011.39
2026-05012.38
2026-06013.23
This device (reports/month)Average device in ETN, GWF, IKN, PDQ (reports/device/month)

Regulatory clearances

  • K182542 SESE 2019-02-22 (k number procode)

Predicate lineage

K182542 — cites (transitively): K061639 (d1), K083124 (d1), K110410 (d1), K132616 (d1), K162383 (d1), K072964 (d2), K924226 (d2), K093304 (d2), K123843 (d2), K070907 (d2), K112052 (d2), K113184 (d2), K971214 (d2), K010590 (d3), K102610 (d3), K890495 (d3), K924723 (d3), K965065 (d3), K984052 (d3), K991054 (d3), K100186 (d3), K061213 (d4), K063580 (d4), K060584 (d4), K073415 (d4), K981405 (d4) — cited as predicate by K182617, K213849

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