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HiJAK™ Cervical

Model 1119-10-0010 · ATLAS SPINE, INC. · DI M68111191000100

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-06 · 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.

23572019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1.17/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 6.67/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3.56/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.33/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1.57/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.33/device2020-08: 0 reports for this device; peer average 1.42/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.58/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 1.71/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 4.05/device2021-07: 0 reports for this device; peer average 1.25/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.38/device2022-01: 0 reports for this device; peer average 1.25/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 1.64/device2022-04: 0 reports for this device; peer average 1.2/device2022-05: 0 reports for this device; peer average 1.85/device2022-06: 0 reports for this device; peer average 1.4/device2022-07: 0 reports for this device; peer average 1.29/device2022-08: 0 reports for this device; peer average 1.43/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 1.33/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.57/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 5.78/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.6/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 4/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 1.2/device2024-11: 0 reports for this device; peer average 1.6/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.43/device2025-02: 0 reports for this device; peer average 1.78/device2025-03: 0 reports for this device; peer average 1.4/device2025-04: 0 reports for this device; peer average 1.88/device2025-05: 0 reports for this device; peer average 1.25/device2025-06: 0 reports for this device; peer average 1.6/device2025-07: 0 reports for this device; peer average 2.4/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.33/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1.83/device2025-12: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 1.38/device2026-02: 0 reports for this device; peer average 1.38/device2026-03: 0 reports for this device; peer average 1.63/device2026-04: 0 reports for this device; peer average 1.38/device2026-05: 0 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.89/device02030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0301
2019-0401
2019-0501.5
2019-0601.17
2019-0702
2019-0806.67
2019-0901
2019-1003.56
2019-1101.33
2019-1201
2020-0101.33
2020-0202
2020-0301.5
2020-0401.5
2020-0501.57
2020-0601
2020-0701.33
2020-0801.42
2020-0901
2020-1001.58
2020-1101
2020-1202
2021-0101.25
2021-0201.5
2021-0301.71
2021-0401
2021-0501
2021-0604.05
2021-0701.25
2021-0801
2021-0901.86
2021-1001
2021-1101
2021-1201.38
2022-0101.25
2022-0201.5
2022-0301.64
2022-0401.2
2022-0501.85
2022-0601.4
2022-0701.29
2022-0801.43
2022-0902.11
2022-1001.33
2022-1102
2022-1201
2023-0201
2023-0301.57
2023-0401
2023-0501.5
2023-0601
2023-0701
2023-0805.78
2023-0901
2023-1001.6
2023-1101
2023-1201.25
2024-0104
2024-0201.5
2024-0301.5
2024-0401.5
2024-0501.33
2024-0601.5
2024-0701.67
2024-0802
2024-0901.67
2024-1001.2
2024-1101.6
2024-1201.71
2025-0101.43
2025-0201.78
2025-0301.4
2025-0401.88
2025-0501.25
2025-0601.6
2025-0702.4
2025-0801.67
2025-0901.33
2025-1001.5
2025-1101.83
2025-1201.67
2026-0101.38
2026-0201.38
2026-0301.63
2026-0401.38
2026-0501.71
2026-0601.89
This device (reports/month)Average device in ODP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K180675 — cites (transitively): K121649 (d1), K130948 (d1), K162918 (d1), K163491 (d1), K100889 (d2), K101812 (d2), K083167 (d2), K063205 (d2), K072289 (d2), K080537 (d2), K091638 (d2), K102293 (d2), K143479 (d2), K152475 (d2), K152501 (d2), K153400 (d2), K150362 (d2), K082801 (d3), P980048 (d3), K073351 (d3), K081917 (d3), K092904 (d3), K072970 (d3), K093242 (d3), K071724 (d3), K151472 (d3), P950002 (d3), P960025 (d3), K081611 (d3), K140003 (d3), K140921 (d3), K142050 (d3), K142264 (d3), K103111 (d3), K141953 (d3), K150643 (d3), K113447 (d3), K140280 (d3), P950019 (d3), K090566 (d3), K100089 (d3), K113527 (d3), K123231 (d3), K123752 (d3), K133813 (d3), K073202 (d4), K083626 (d4), K093669 (d4), K121683 (d4), K123281 (d4), K123206 (d4), K081614 (d4), K110442 (d4), K032812 (d4), K080615 (d4), K083714 (d4), K102067 (d4), K111626 (d4), K140055 (d4), K130177 (d4), K073109 (d4), K101301 (d4), K141942 (d4), K141665 (d4), K141896 (d4), K072791 (d5), K080401 (d5), K081730 (d5), K100214 (d5), K043479 (d5), K071795 (d5), K080699 (d5), K090816 (d5), K113348 (d5), K120918 (d5), K123045 (d5), K130820 (d5), K131082 (d5), K132601 (d5), K133455 (d5), K140319 (d5), K123027 (d5), K140659 (d5), K101310 (d5), K102090 (d5), K111122 (d5), K133200 (d5), K133286 (d5), K073285 (d6), K091088 (d6), K092336 (d6), P000028 (d6), K083186 (d6), K031635 (d6), K080568 (d6), K101923 (d6), K082732 (d6), K023570 (d6), K062933 (d6), K073291 (d6), K082310 (d6), K091278 (d6), K092193 (d6), K100042 (d6), K130548 (d6), K072415 (d6), K043206 (d6), K133623 (d6), K110632 (d6), K122967 (d6), K003836 (d7), K010930 (d7), P970015 (d7), K073348 (d7), K092901 (d7), K082262 (d8) — cited as predicate by K260840

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

Manufacturer compliance record — ATLAS SPINE, INC.

  • VAI 2025-05-27 Atlas Spine, Inc. · 1 citations
  • VAI 2025-05-27 Atlas Spine, Inc. · 1 citations
  • NAI 2022-12-06 Atlas Spine, Inc. · 0 citations
  • NAI 2022-12-06 Atlas Spine, Inc. · 0 citations
  • VAI 2019-07-19 Atlas Spine, Inc. · 3 citations
  • VAI 2019-07-19 Atlas Spine, Inc. · 3 citations
  • VAI 2015-08-26 Atlas Spine, Inc. · 2 citations
  • VAI 2015-08-26 Atlas Spine, Inc. · 2 citations
  • VAI 2012-03-07 Atlas Spine, Inc. · 2 citations
  • VAI 2012-03-07 Atlas Spine, Inc. · 2 citations
  • VAI 2011-03-04 Atlas Spine, Inc. · 8 citations
  • VAI 2011-03-04 Atlas Spine, Inc. · 8 citations